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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/12/14-6/12/14

Meeting Details:

On June 12, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the LUTONIX 035 Drug Coated Balloon PTA Catheter sponsored by Lutonix, Inc. The LUTONIX 035 Drug Coated Balloon PTA Catheter (LUTONIX DCB) is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter with a paclitaxel-based drug coating on the surface of the balloon. The LUTONIX DCB is compatible with a 0.035' guidewire and has balloon sizes ranging from 4 millimeters (mm) to 6 mm in diameter and 40 mm to 100 mm in length. The LUTONIX DCB catheter is available in 75 centimeters (cm), 100 cm and 130 cm working lengths.

 

       
Location: Germantown, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 12/11/13-12/11/13

Meeting Details:

On December 11, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Technology. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is intended to prevent thrombus embolization from the left atrial appendage, thereby preventing the occurrence of ischemic stroke and systemic embolism, and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/8/13-10/9/13

Meeting Details:

On both days the committee will discuss, make recommendations, and vote on devices indicated for use in patients with heart failure (HF). On October 8, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the expansion of indications supported by the BLOCK HF trial to apply to all market-approved Medtronic Cardiac Resynchronization Therapy-Pacemaker (CRT-P) and Cardiac Resynchronization Therapy-Defibrillator (CRT-D) devices. The devices are pulse generators either without (CRT-P) or with (CRT-D) defibrillation capabilities. The devices require the implantation of at least a right ventricular (RV) and a left ventricular (LV) lead for sensing and pacing functionality. The RV lead used with a CRT-D device also has the capability to deliver high voltage energy. The implantation of a right atrial (RA) lead is left to the discretion of the clinician for both devices. The requested expansion in indications for use was studied under the BLOCK HF trial. The trial was a prospective, multisite, randomized, double-blinded, parallel-controlled investigational device exemption (IDE) study. The primary objective of the trial was to demonstrate that the time until the first event of all-cause mortality, heart-failure-related urgent care, or a significant increase in left ventricular end systolic volume index (LVESVI) for subjects programmed to biventricular pacing is superior to that of subjects programmed to right ventricular pacing. 3 On October 9, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for CardioMEMS, Inc. Champion™ HF Monitoring System. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary arterial (PA) pressure. These measurements are used to guide treatment of congestive heart failure. The system consists of the following: Implantable Sensor--The Pressure Sensor consists of a three-dimensional coil and pressure-sensitive capacitor encased between two wafers of fused silica. The coil (inductor) electromagnetically couples to the Sensor and allows the remote measurement of the resonant frequency of the inductive/capacitive (LC) circuit. This allows for wireless communication with the Sensor and eliminates the need for an onboard source of energy, such as a battery. Delivery System--The Delivery System allows the placement of the Pressure Sensor within the distal pulmonary artery. There are two versions of the Delivery System. The first includes a hydrophilic coating on the distal portion of the catheter shaft and the second has no coating on the catheter shaft. Both delivery catheters are compatible with a guidewire. The Delivery System (with HF Sensor) is introduced over a guidewire through a sheath. Tether wires connect the Sensor to the Delivery System until the physician determines that the Sensor is properly positioned within the distal pulmonary artery. Once the Sensor is in position, the tether wires are withdrawn, releasing the Sensor. Electronics Unit (Interrogator) and database--The Electronics Unit contains hardware and software to acquire and process signals from the sensor, provides a system interface for both patients and clinicians, and transfers PA measurements to a database for review by medical 4 professionals. The database is a Web-based server that contains software, which receives data transmitted from the electronics unit, and presents the data for review by medical professionals.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 9/11/13-9/12/13

Meeting Details:

On September 11, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC) devices, one of the remaining preamendments class III devices regulated under the section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) (510(k)) pathway. ECCs, also known as chest compressors, assist in the act of cardiopulmonary resuscitation (CPR). The devices in this classification are divided into two types: (1) Devices that provide automatic chest compressions at a fixed compression rate and depth (automated ECCs), which are placed directly on the patient's chest and are powered manually, pneumatically, or electrically and (2) devices that aid the emergency medical professional in delivering manual compressions at a compression depth and rate that are consistent with current guidelines (CPR Aids). These devices are placed beneath the hands of the emergency medical professional or in the vicinity of the cardiac arrest victim and provide audio and/or visual feedback to assist emergency personnel in following the recommended steps for CPR and maintaining the recommended rate and depth of compressions for the duration of CPR. On January 8, 2013 (78 FR 1162), FDA issued a proposed order which, if made final, would make the class III ECC devices class II subject to special controls and, except as noted below, premarket notification (510(k)). The CPR aid device is proposed to be exempt from section 510(k) of the FD&C Act if it is a prescription use device that provides feedback to the rescuer consistent with the current American Heart Association guidelines for CPR and in compliance with the special controls, subject to the limitations of exemptions in 21 CFR 870.9. (3) The regulatory history of ECC devices has been discussed as part of the proposed rule (77 FR 36951, June 20, 2012). The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class I or class II. The committee will further be asked to comment on whether general and/or special controls are adequate to assure the safety and effectiveness of the device and whether, if reclassified to class II, these devices should be exempt from premarket notification requirements. On September 11, 2013, during session II, the committee will discuss and make recommendations regarding classification of external pacemaker pulse generators (EPPGs), one of the remaining preamendments class III devices regulated under the 510(k) pathway. An EPPG is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables. On October 17, 2011 (76 FR 64224), FDA issued a proposed rule which, if made final, would make the class III external pacemaker pulse generator devices class II subject to premarket notification (510(k)) and special controls. The regulatory history of external pacemaker pulse generator devices has been discussed as part of the proposed rule (77 FR 36951). (4) The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to PMA) or reclassify to class II and comment on whether special controls are adequate to assure the safety and effectiveness of this device. Also during session II, FDA will be seeking feedback from the committee regarding classification of triple chamber pacing system analyzers (PSAs) with external pacing capability, a postamendments device classified through the premarket approval process as class III. A triple chamber PSA is intended to be used during the implant procedure of pacemakers and defibrillators, including biventricular devices, to evaluate the placement and integrity of pacing leads for determination of appropriate pacing parameters for the implanted device. The device provides pacing and sensing in up to three chambers during the implant procedure. The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to PMA) or reclassify to class II and comment on whether special controls are adequate to assure the safety and effectiveness of this device. On September 12, 2013, the committee will discuss and make recommendations regarding the proposed classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendments class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as an ECMO. An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is (5) comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is intended for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management. On January 8, 2013 (78 FR 1158), FDA issued a proposed order which, if made final, would make the class III ECMO devices class II subject to premarket notification (510(k)) and special controls. The regulatory history of ECMO devices has been discussed as part of the proposed rule (78 FR 1158). The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to PMA) or reclassify to class II and comment on whether special controls are adequate to assure the safety and effectiveness of this device.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 3/20/13-3/20/13

Meeting Details:

On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device. The MitraClip device is a single sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation. The MitraClip device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The implantable MitraClip device is fabricated with metal alloys and polyester fabric (Clip cover) that are commonly used in cardiovascular implants. The proposed indication for use: The MitraClip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR=3) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not preclude the expected benefit from correction of the mitral regurgitation.

 

       
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 12/5/12-12/6/12

Meeting Details:

On December 5, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for the external counter-pulsating (ECP) devices, one of the remaining pre-Amendment Class III devices. These systems typically consist of a treatment table, pressure cuffs and a controller. They are intended to provide noninvasive circulatory support by applying external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and releasing external pressure during systole to reduce left ventricular workload.On December 5, 2012, during session II, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for Intra-aortic balloon and control systems, one of the remaining pre-Amendment Class III devices. Intra-aortic balloon pump (IABP) systems consist of an inflatable balloon and a console which inflates in synchronization with the cardiac cycle. During diastole, the balloon will inflate, creating a rise in pressure in the aorta, thus increasing blood flow to the coronary arteries and increasing myocardial oxygen supply. During systole, deflation of the balloon causes a fall in pressure in the aorta, which assists the left ventricle by reducing the pressure that needs to be generated to achieve ejection through the aortic valve.On December 6, 2012, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for Nonroller-type cardiopulmonary bypass blood pumps, one of the remaining pre-Amendment Class III devices. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump blood. There are two types of nonroller-type pumps which have been reviewed by the Agency: 1) Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. These pumps are part of an extracorporeal circuit usually containing an oxygenator and are intended to provide cardiopulmonary support, during procedures such as cardiopulmonary bypass surgery, for periods lasting 6 hours or less. 2) Micro-axial type pumps are comprised of a pump motor, a cannula and a catheter that connects to a console. These pumps are not designed to be used with an oxygenator but are temporarily placed within the heart or vasculature to provide cardiac support only.

 

       
Location: Holiday Inn, Grand Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory

Meeting Date: 6/13/12-6/13/12

Meeting Details:

On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 5/24/12-5/24/12

Meeting Details:

On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Device was the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more information has become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose of discussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 4/25/12-4/26/12

Meeting Details:

On April 25, 2012, the committee will discuss, make recommendations and vote on information related to a supplement to the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable electrically powered centrifugal-flow rotary blood pump with external driver and power source(s). It is the first ventricular assist device that does not require the creation of an abdominal pump pocket. The HVAS is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced heart failure. On April 26, 2012, the committee will discuss, make recommendations and vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S–ICD) System sponsored by Cameron Health, Inc. The S–ICD is the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. The S–ICD is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias. The device is capable of delivering high energy defibrillation shocks as well as bradycardia demand mode cardiac pacing. The study provides data from the treatment of induced acute and chronic episodes of ventricular tachycardia/ventricular fibrillation and spontaneous episodes. In addition to the investigational device exemption study, clinical data were also obtained from using studies outside the United States and registries.

 

       
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 12/7/11-12/8/11

Meeting Details:

On December 7, 2011, the committee will discuss, make recommendations, and vote on information related to a supplement tothe premarket approval application (PMA) P010031, sponsored by Medtronic, Inc. Medtronic is requesting FDA approval to expand the indications for use for all commercially available Medtronic Cardiac Resynchronization Therapy Defibrillator (CRT¨CD) devices covered under PMA P010031. The company has proposed the following expanded indication statement based on the results of the REVERSE and RAFT clinical studies: ¡®¡®Medtronic cardiac resynchronization therapy defibrillator (CRT¨CD) systems are indicated for heart failure patients who meet the following classification: NYHA Functional Class II who remain symptomatic despite stable, optimal medical therapy, and who have left bundle branch block (LBBB) with a QRS duration ¡Ý120 ms, and left ventricular ejection fraction ¡Ü30%.¡¯¡¯ On December 8, 2011, the committee will discuss, make recommendations, and vote on information related to the PMA for the CardioMEMS HF Pressure Measurement System (HF System) sponsored by CardioMEMS, Inc. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary artery pressure. These measurements are used to guide treatment of congestive heart failure.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical

Meeting Date: 10/26/11-10/27/11

Meeting Details:

On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator. On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately.

 

       
Location: Hilton Washington, DC, North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 7/20/11-7/21/11

Meeting Details:

On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN\TM\ Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to-transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 1/25/11-1/26/11

Meeting Details:

On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k))), as directed by section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)). On January 26, 2011, the committee will discuss, make recommendations and vote on information related to the PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX Acculink is indicated for treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows: 1. Patients with neurological symptoms and >50 percent stenosis of the common or internal carotid artery or patients without neurological symptoms and >80 percent (high risk) or >70 percent (standard risk) stenosis of the common or internal carotid artery and 2. Patients must have a reference vessel diameter within the range of 4.0 and 9.0 mm at the target lesion.

 

       
Location: Holiday Inn - Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/18/10-3/19/10

Meeting Details:

On March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRTDs) sponsored by Boston Scientific. The sponsor is seeking expanded indications for the their CRTDs to include patients with low left ventricular ejection fraction (¡Ü30%) and wide QRS (¡Ý130 ms) who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology). On March 19, 2010, the committee will discuss, make recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.

 

       
Location: College Park Holiday Inn Grand Ballroom 10000 Baltimore Ave. College Park, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 7/22/09-7/23/09

Meeting Details:

On July 22, 2009, the committee will discuss, make recommendations, and vote on a Humanitarian Device Exemption (HDE) application, sponsored by Medtronic, Inc., for the MEDTRONIC MELODY Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE Transcatheter Valve Delivery System (NU10). The MEDTRONIC MELODY Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE Transcatheter Valve Delivery System (NU10) is indicated for use in patients with the following clinical conditions: Regurgitant (insufficient or leaky) Right Ventricular Outflow Tract (RVOT)The right ventricular outflow tract is that portion of the right ventricle leading up to the pulmonary valve and pulmonary artery. When the ventricles contract, blood moves along the outflow tract and through the pulmonary valve; blood then flows to the lungs where gas exchange takes place. ConduitsIn the context of this device, a surgically implanted tube that allows blood to pass from the heart to the pulmonary arteries.&sbull;Stenotic (stiff valve leaflets that cannot open or close properly) RVOT conduits where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting.&sbull;Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 millimeters (mm) in diameter when originally implanted. On July 23, 2009, from 8 a.m. to 10 a.m., and from 1 p.m. to 6 p.m., the committee will discuss general questions about adhesion barriers for cardiovascular use. Some of these questions will focus on understanding the target population (pediatric and/or adult) that would benefit from these devices and the development of appropriate endpoints for a clinical trial.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 4/23/09-4/23/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Atritech, Inc., for the WATCHMAN® Left Atrial Appendage (LAA) Closure Technology. The WATCHMAN® device, a percutaneously placed permanent implant, is intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation. The WATCHMAN® LAA Closure Technology is designed to prevent embolization of thrombi that may form in the left atrial appendage thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/18/09-3/18/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients were randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directly to the infarction site of the heart. This therapy is intended to be performed for 90 minutes post percutaneous coronary intervention/stenting.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 11/20/08-11/20/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Biosense Webster, Inc., a Johnson & Johnson Company, for the NaviStar ThermoCool irrigated RF ablation catheter. The device, an open-lumen, irrigated tip, steerable radiofrequency cardiac ablation catheter, is inserted through the venous circulation to the heart, across the intra-atrial septum to the left atrium to ablate cardiac tissue for the purposes of creating lines of block in the atria to eliminate conduction patterns that theoretically generate or allow propagation of paroxysmal atrial fibrillation.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 11/29/07-11/30/07

Meeting Details:

Agenda: On November 29, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Abbott Vascular, for the XIENCE V Everolimus Eluting Coronary Stent System, which is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length = 28 millimeters (mm)) with reference vessel diameter of 2.5 mm to 4 mm. On November 30, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored. by Thoratec Corp., for the HeartMate I1 Left Ventricular Assist System (LVAS), which is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate I1 LVAS is intended for use both inside and outside the hospital.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/10/07-10/11/07

Meeting Details:

On October 10, 2007, the committee will discuss; make recommendations; and vote on a premarket approval application, sponsored by Medtronic, Inc., for the Endeavor Zotarolimus-Eluting Coronary Stent System, which is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length < = 27 millimeters (mm) in native coronary arteries with reference vessel diameters of >= 2.5 mm to <= 3.5 mm. On October 11, 2007, the committee will discuss and make recommendations regarding clinical trial designs for carotid artery stenting in patients not at high risk for adverse events from surgical revascularization.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 9/19/07-9/20/07

Meeting Details:

On September 19, 2007, the committee will discuss, make recommendations and vote on a premarket approval application, sponsored by SyntheMed, Inc., for the REPEL-CV, which is a surgical adjuvant indicated for reducing the incidence, severity and extent of post- operative adhesion formation in patients undergoing cardiac surgery. On September 20, 2007, the committee will discuss and make recommendations regarding clinical trial designs for cardiac ablation devices designed to treat patients with medically refractory atrial fibrillation.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/27/07-6/27/07

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by CryoCor Inc., for the CryoCor Cryoablation System, which is intended for the treatment of isthmusdependent atrial flutter in patients 18 years or older.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/1/07-3/2/07

Meeting Details:

On March 1, 2007, the committee will discuss and make recommendations regarding the premarket approval application, sponsored by Medtronic Inc., for the Chronicle Implantable Hemodynamic Monitoring System. This implantable device is intended to reduce hospitalization events or equivalent events for worsening heart failure in patients with moderate to advanced heart failure. On March 2, 2007, the committee will discuss and make recommendations regarding clinical trial designs for Patent Foreman Ovale closure devices intended to prevent recurrent stroke.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 12/7/06-12/8/06

Meeting Details:

The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/22/05-6/23/05

Meeting Details:

(Sponsor: Acorn Product: CorCap)On June 22, 2005, the committee will discuss, make recommendations, and vote on a premarket approval application for a cardiac device intended to treat patients with heart failure. (Sponsor: Abiomed Product: AbioCor)On June 23, 2005, the committee will discuss, make recommendations, and vote on a humanitarian device exemption for an artificial heart.

 

       
Location: Hilton Washington DC Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 4/22/05-4/22/05

Meeting Details:

Sponsor of Meeting: Cardica Inc.’s device PAS-Port. But First the committee will hear a presentation by the Office of Surveillance and Biometrics outlining their responsibility for the review of postmarket study design. Then the committee will also hear an update on the status of recent devices brought before the committee. Finally the committee will discuss and make recommendations on a premarket notification submission for a coronary proximal anastomosis device(Cardica Inc.’s device PAS-Port).

 

       
Location: HOL Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/17/05-3/17/05

Meeting Details:

The committee will discuss and make recommendations on CoolGardy catheter by Alsyius regarding a premarket notification submission for use in the induction, maintenance and reversal of mild hypothermia in the treatment of unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest when the initial rhythm was ventricular fibrillation.

 

       
Location: Hilton Washington DC North Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 1/13/05-1/13/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative. The committee will also discuss, make recommendations, and vote on a premarket approval application for a thoracic endoprosthesis intended for endovascular repair of the descending thoracic aorta.

 

       
Location: Hilton Washington DC North The Ballrooms 620 Perry Parkway Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 9/21/04-9/21/04

Meeting Details:

The committee will discuss and make recommendations regarding clinical trial design in the evaluation of cardiopulmonary resuscitation enhancing devices/therapies for cardiac arrest patients.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 7/28/04-7/29/04

Meeting Details:

On July 28, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application supplement for a cardiac resynchronization device. On July 29, 2004, the committee will hear a presentation on Adverse Event Reports for Automatic External Defibrillators from 1996 – 2003. The committee will also discuss and make recommendations on a premarket notification (510(k)) submission for an Over-the-Counter Automated External Defibrillator.

 

       
Location: Holiday Inn, Grand Ballroom Two Montgomery Village Ave. Gaithersburg , MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 6/8/04-6/8/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a left ventricular assist system. The system is intended for use as a short or long term bridge to transplantation in cardiac transplant patients, and in patients with relative contraindication to transplantation who are expected to become transplant candidates with mechanical circulatory support, at risk of imminent death from nonreversible left ventricular failure. The device is indicated for use both inside and outside of the hospital.

 

       
Location: Hilton Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 4/21/04-4/21/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a carotid stent indicated for use in the treatment of carotid artery disease in high-risk patients.

 

       
Location: Rio Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 3/17/04-3/18/04

Meeting Details:

On March 17, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application for a Total Artificial Heart indicated for bridge to transplant usage in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure and replacing the patient's native ventricles and valves. The device is intended for use inside the hospital. On March 18, 2004, FDA will present to the committee the history, current medical practice, and regulatory background regarding Aortic Anastomotic Devices. The committee will discuss and make recommendations regarding the type of data and study required to effectively evaluate performance of Aortic Anastomotic Devices for marketing, recognizing the significant public health impact on cardiac disease they represent.

 

       
Location: Hilton Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 11/20/03-11/20/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a drug-eluting stent indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions.

 

       
Location: Hilton Gaithersburg , MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 10/2/03-10/2/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an excimer laser and laser catheters used for treatment of chronic critical limb ischemia (associated with Rutherford Categories 4, 5 and 6). The device is intended for use in patients with angiographically evident culprit stenoses and/or occlusions in the superficial femoral artery, popliteal and/or infrapopliteal arteries, who are poor surgical candidates and who are acceptable candidates for revascularization.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 5/29/03-5/29/03

Meeting Details:

The committee will hear a presentation on post-market surveillance of diathermy interactions with implanted leads and implanted systems with leads. The committee will also discuss, make recommendations, and vote on a premarket approval application for an ablation catheter for treatment of atrial fibrillation in patients with drug refractory paroxysmal atrial fibrillation.

 

       
Location: Holiday Inn - GB Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 4/10/03-4/10/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an endovascular graft and delivery system intended for treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysm.

 

       
Location: Gaithersburg , MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/6/03-3/6/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a thermal (cold) cardiac ablation catheter and generator system intended for cryoablation of cardiac tissue to treat patients with atrioventricular tachycardia and for mapping of the atrioventricular node.

 

       
Location: Gaithersburg Marriott Gaithersburg , MD Related News Links: Not Available
Time: 10:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/22/02-10/23/02

Meeting Details:

On October 22, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application for a drug-coated coronary artery stent intended to treat coronary artery obstructions and to help prevent in-stent stenosis. On October 23, 2002, the committee will discuss and make recommendations on a premarket notification (510(k)) submission for an arterial cannula intended to prevent an adverse neurological or limb threatening event.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 9/9/02-9/10/02

Meeting Details:

On September 9, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an endovascular graft placed percutaneously to treat infrarenal abdominal aortic aneurysms as an alternative to surgery. On September 10, 2002, the committee will discuss, make recommendations, and vote on a supplement to a PMA for a double disk occluder indicated for closure of patent foramen ovale in patients at risk for recurrent cryptogenic stroke or transient ischemic attack.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/4/02-3/5/02

Meeting Details:

On March 4, 2002, the committee will discuss, make recommendations, and vote on a supplement to a premarket approval application (PMA) for a left ventricular assist device to be used as destination therapy in patients with end stage congestive heart failure. On March 5, 2002, the committee will discuss, make recommendations, and vote on a PMA for an implantable pacemaker/defibrillator used for treatment of both congestive heart failure and life threatening dysrhythmias.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 9/10/01-9/11/01

Meeting Details:

No Webcasting for September 10, 2001, the committee will discuss, make recommendations, and vote on two premarket approval applications (PMA’s) for septal occluders. VIDEOTAPES ARE AVAILABLE!!!! On September 11, 2001, the committee will discuss, make recommendations, and vote on two PMA’s, one for a surgical sealant and one for a biological glue.

 

       
Location: Gaithersburg Marriott Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 7/9/01-7/10/01

Meeting Details:

On July 9, 2001, the committee will hear brief presentations on issues related to endovascular grafting systems for the treatment of abdominal aortic aneurysms. The committee will then discuss, make recommendations, and vote on a premarket approval application (PMA) for a percutaneous myocardial revascularization system used in the treatment of angina. On July 10, 2001, the committee will discuss, make recommendations, and vote on two separate PMA’s for implantable cardiac devices used in the treatment of congestive heart failure. Background information for each day’s topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 9 meeting will be posted on July 6, 2001; material for the July 10 meeting will be posted on July 9, 2001.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 4/23/01-4/23/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a peripheral stent used in the treatment of stenotic or occluded femoral or popliteal arteries. Subsequently, the committee will discuss clinical study design issues for peripheral stents used in the treatment of stenotic or occluded iliac arteries.

 

       
Location: Silver Spring, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory Systems Devices Panel

Meeting Date: 2/5/01-2/5/01

Meeting Details:

On February 5, 2001, the committee will discuss and make recommendations on a premarket submission for a distal protection device used in the treatment of saphenous vein graft disease. Subsequently, the committee is being asked to provide input to the agency regarding the design of clinical trials for distal protection devices.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 12/4/00-12/5/00

Meeting Details:

On December 4, 2000, the committee will discuss and make recommendations on a reclassification petition proposing to down-classify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters from Class III to Class II. --- Day 2 --- On December 5, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application for an implantable cardioverter defibrillator used in the treatment of atrial fibrillation.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory Systems Devices

Meeting Date: 9/11/00-9/11/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an intravascular radiation device used in the treatment of instent restenosis.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory Systems Devices

Meeting Date: 6/19/00-6/20/00

Meeting Details:

On June 19, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application for an intravascular radiation device used in the treatment of instent restenosis. On June 20, 2000, the committee will discuss a modification to the guidance document titled, "DRAFT Guidance for Implantable Cardioverter-Defibrillators". Specifically, the modification would allow general indications for use for implantable cardioverter defibrillators. The guidance document, version 4.3, was issued June 24, 1996.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory Systems Devices

Meeting Date: 4/4/00-4/4/00

Meeting Details:

Subsequently, the committee is being asked to provide input to the agency regarding the design of clinical trials for the following: 1) devices using spinal cord stimulation in the treatment of angina pectoris; 2) rate-responsive pacemakers, specifically the evaluation of rate-adaptive features; and 3) devices used in the treatment of atrial fibrillation. There will be a brief FDA presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory Systems Devices

Meeting Date: 6/23/99-6/24/99

Meeting Details:

On June 23, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an endovascular graft for the treatment of abdominal aortic aneurysms. Subsequently, the committee will discuss, make recommendations, and vote on a PMA for an endovascular graft for the treatment of abdominal aortic or aorto-iliac aneurysms. On June 24, 1999, the committee will discuss, make recommendations, and vote on a PMA for a prosthetic heart valve. Subsequently, the committee will discuss, make recommendations, and vote on a PMA for a dual-chamber defibrillator for the treatment of atrial and ventricular tachyarrhythmias. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Gaithersburg Hilton Salons C, D, and E 620 Perry Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices

Meeting Date: 12/7/98-12/7/98

Meeting Details:

The committee will discuss and make recommendations on clinical trial requirements for future approval of coronary stents. An outline of the types of issues to be discussed by the committee can be found on the FDA website at http://www.fda.gov/cdrh/upadvmtg.html. Single copies of this outline are also available to the public by contacting the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, at 1-800-638-2041 or 301-443-6597.

 

       
Location: Holiday Inn Gaithersburg Two Montgomery Village A Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices

Meeting Date: 10/27/98-10/27/98

Meeting Details:

The commmittee will discuss, make recommendations and vote on a premarket approval application for a transmyocardial revascularization device.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices

Meeting Date: 7/21/98-7/22/98

Meeting Details:

On July 21, 1998, the committee wil discuss, make recommendations, and vote on a premarket approval application (PMA) for a cardiac ablation devices for ventrcular tachcardia. On July 22, 1998, the committee is being asked to provide imput to the agency regarding the design of clinical trials to support PMA’s for cardiac ablation devices intended to treat atrial fibrilation and atrial flutter. Of particular concern are the following issues: (1) What are the appropriate controls to be used in such trials? (2) What are the appropriate safety and efficacy measures? and (3) When should assessments of these measures be made?

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices

Meeting Date: 6/29/98-6/30/98

Meeting Details:

On June 29, the committee will discuss a premarket approval application for an external compression device used incardiopulmonary resuscitation. On June 30, the committee will discuss and make recommendations on permanent cardiovascular implants such as heart valves and vascular grafts.

 

       
Location: Corporate Building, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

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Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

Meeting Date: 9/9/14-9/9/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/10/14-9/10/14

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Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMethodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

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Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 9/11/14-9/11/14

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (NPS Pharma)

Meeting Date: 9/12/14-9/12/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

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Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

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Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

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Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

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Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Comm

Meeting Date: 7/31/14-7/31/14

Meeting Details:

On the morning of July 31, 2014, the committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Past Meetings

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