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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 4/17/15-4/17/15

Meeting Details:

On April 17, 2015, the committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology. FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies, for flow diverter technology indicated for the neurovasculature.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 2/22/13-2/22/13

Meeting Details:

On February 22, 2013, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace Responsive Neurostimulation (RNS) System sponsored by NeuroPace, Inc. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 12/10/12-12/10/12

Meeting Details:

On December 10, 2012, the committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Neurological Devices Panel

Meeting Date: 11/1/12-11/1/12

Meeting Details:

On November 1, 2012, the committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset.

 

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

Meeting Date: 3/23/12-3/23/12

Meeting Details:

On March 23, 2012, the committee will discuss current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. The Wingspan Stent System with Gateway PTA Balloon Catheter is a neurovascular stent, balloon catheter, and delivery system consisting of the following components: 1. Wingspan Stent--This is a self-expanding, nitinol stent with a tubular mesh design. 2. Gateway PTA Balloon Catheter--This balloon catheter is used to predilate the lesion prior to introduction of the Wingspan Stent System into the patient. 3. Wingspan Delivery System--This delivery system is a single lumen, over-the-wire, coaxial microcatheter that is used to deliver the stent to the treatment site within the patient's artery.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-7:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 2/10/12-2/10/12

Meeting Details:

On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov1 under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.

 

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

Meeting Date: 3/17/11-3/18/11

Meeting Details:

On March 17, 2011, the committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the NovoTTF-100A Treatment Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A Treatment Kit is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra-tentorial region of the brain. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy for GBM. On March 18, 2011, the committee will discuss, make recommendations and vote on information related to the PMA for the PIPELINE EMBOLIZATION Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the paraclinoid region of the internal carotid artery.

 

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

Meeting Date: 1/27/11-1/28/11

Meeting Details:

On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 10/8/10-10/8/10

Meeting Details:

The committee will discuss and make recommendations regarding clinical trial design issues for devices indicated for the treatment of depression.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/12/10-3/12/10

Meeting Details:

On March 12, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a patient's epilepsy should be characterized by partial-onset seizures (affecting only a part of the brain when they begin), with or without secondary generalization that are refractory to antiepileptic medications. ``Secondary generalization'' is used to describe a partial-onset seizure that later spreads to the whole brain. ``Refractory'' to antiepileptic medications means that the patient's epilepsy does not respond to approved medications.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Neurological Devices Panel of the Medical Devices

Meeting Date: 11/20/09-11/20/09

Meeting Details:

*** Meeting Postponed *** On November 20, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a patient's epilepsy should be characterized by partial-onset seizures (affecting only a part of the brain when they begin), with or without secondary generalization, that are refractory to antiepileptic medications. Secondary generalization is used to describe a partial-onset seizure that later spreads to the whole brain. Refractory to antiepileptic medications means that the patient's epilepsy does not respond to approved medications.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 5/14/09-5/14/09

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for the DuraSeal XactTM Sealant System, sponsored by Confluent Surgical Inc. This device is indicated for use as an adjunct to sutured dural repair to obtain watertight closure during spinal surgery.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 1/26/07-1/26/07

Meeting Details:

The committee will discuss and make recommendations on a premarket notification application, sponsored by Neuronetics, Inc., for the NeuroStar System for the treatment of major depressive disorder. The committee will also hear and discuss post approval study reports for two recently approved neurological device premarket approval applications: The VNS Therapy\TM\ System, sponsored by Cyberonics, Inc., for treatment-resistant chronic or recurrent depression; and the Dural Sealant System, sponsored by Confluent Surgical, Inc., for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 10/31/06-10/31/06

Meeting Details:

The committee will discuss and make recommendations on a premarket notification application for a device intended for the treatment of major depressive disorder. The committee will also hear and discuss the post approval study reports for two recently approved neurological device premarket approval applications.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 6/17/05-6/17/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also hear an update on the status of recent devices brought before the committee. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for a selective head cooling system intended for use in infants 36 weeks of gestation or older at risk for moderate to severe hypoxic-ischemic encephalopathy (HIE) to prevent or reduce the severity of HIE.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices

Meeting Date: 11/30/04-11/30/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 6/15/04-6/15/04

Meeting Details:

The committee will discuss, make recommendations, and vote on premarket approval application supplement for a vagus nerve stimulation therapy system. The system is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients who are experiencing a major depressive episode that has not had an adequate response to two or more antidepressant treatments.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/23/04-2/23/04

Meeting Details:

The committee will discuss and make recommendations on a premarket notification submission for a thrombectomy device.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Panel

Meeting Date: 8/5/03-8/5/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a neurological embolization device.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 11/17/00-11/17/00

Meeting Details:

The committee will discuss and make recommendations on: (1) the design of clinical trials for devices to prevent stroke, to treat stroke, and to provide neurological protection after stroke, and (2) the design of clinical studies for temperature control devices to provide neurological protection.

 

       
Location: Quality Suites Hotel Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 5/11/00-5/11/00

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for an embolization device.

 

       
Location: Corporate Blvd., Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/31/00-3/31/00

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for a deep brain stimulator for the treatment of Parkinson's disease. The device is a product of the Medtronic Corporation.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 9/16/99-9/17/99

Meeting Details:

On September 16, 1999, the committee will discuss and make recommendations on: (1) the draft FDA guidance document "Guidance Document for Dura Substitute Devices"; and (2) the classification of processed human dura mater. FDA notes that a guidance document related to the classification of processed human dura mater "Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater" became effective on July 31, 1999. On September 17, 1999, the committee will discuss and make recommendations on: (1) the draft FDA guidance document "Guidance Document for Neurological Embolization Devices"; and (2) the reclassification of the totally implanted spinal cord stimulator.

 

       
Location: Corporate Bldg. Conference room 020B 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological CFS Shunts

Meeting Date: 1/8/99-1/8/99

Meeting Details:

Our agenda will include four primary sessions with presentations from leaders in the field of neurosurgery and representatives from FDA and CDC. Following the four issue-specific sessions a panel will convene to focus on setting priorities for future efforts in research and development of shunt technology. Session topics include: Shunt Technology Perspectives Pathophysiology and Evaluation of Shunt Performance Challenges of Infection and New Perspectives Clinical Outcomes and Methods of Surveillance PANEL DISCUSSION: "Future Directions – Establishing Priorities"

 

       
Location: National Naval Medical Center Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 6/12/98-6/12/98

Meeting Details:

Introduction to 515(i) Reclassification Deliberations for the Artificial Embolization Device Intended for Neurological use.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/10/15-9/10/15

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. It has been formulated with the intent to provide abuse-deterrent properties. The pharmacokinetic data demonstrate that there is a significant food effect resulting in a significant delay in absorption and peak plasma concentration of oxycodone when taken with food. The applicant proposes to address this finding by labeling the product to be taken on an empty stomach, but patients may have difficulty complying with these instructions as the product is dosed every 4 to 6 hours as needed. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the delayed peak concentration when taken with food, and the feasibility of labeling to be taken an empty stomach as a means to mitigate the potential risks. The committees will also be asked to consider whether the potential public health benefit of the product’s abuse-deterrent properties are sufficient to outweigh the risk to patients who are prescribed the product for the management of pain.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic with DSRM

Meeting Date: 9/11/15-9/11/15

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Meeting Details:

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. This product has been formulated with the intent to provide abuse-deterrent properties. Pharmacokinetic data demonstrate that, in order to deliver the intended amount of oxycodone, the drug product must be taken with food. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the extent of the food effect, and potential fluctuations in oxycodone levels that may occur if the product is not taken consistently with the same amount of food. In addition, the committees will be asked to review and discuss whether the data characterizing the abuse-deterrent properties support the likelihood that this drug product will have a meaningful effect on abuse and whether potential benefits to the public from abuse-deterrent properties outweigh potential risks to patients from the effect of food. The committees will be asked to vote on whether this product should be approved for marketing in the United States.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory

Meeting Date: 9/15/15-9/15/15

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Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/16/15-9/16/15

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Meeting Details:

On Wednesday, September 16, 2015, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for the PLEXIMMUNE, ELANA SURGICAL KIT (HUD), Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), ENTERRA™ Therapy System, and CONTEGRA Pulmonary Valved Conduit.

 

       
Location: Double Tree by Hilton 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

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Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 10/23/15-10/23/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 11/3/15-11/3/15

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Meeting Details:

The committee will discuss new drug application (NDA) 207959, enclomiphene citrate 12.5 milligram (mg) and 25 mg capsules, submitted by Repros Therapeutics, Inc., for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25 kilograms (kg)/meters squared (m2).

 

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