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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNew Date: Orthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/20/15-2/20/15

Meeting Details:

On February 20, 2015, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

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

Meeting Details:

On December 12, 2013, during Session I, the committee will discuss and make recommendations regarding the classification of spinal sphere devices. These devices are spheres manufactured from metallic (e.g., cobalt chromium molybdenum) or polymeric (e.g., polyetheretherketone) materials. They are intended to be inserted between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft. These devices are not intended for use in motion-sparing, non-fusion procedures. Spinal sphere devices are considered preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Spinal sphere devices are currently regulated under the heading of "Intervertebral Fusion Device with Bone Graft, Solid-Sphere, Lumbar", Product Code NVR, as unclassified devices and reviewed under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness of spinal sphere devices and the regulatory classification for spinal sphere devices. On December 12, 2013, during Session II, the committee will discuss and make recommendations regarding the reclassification petition received on November 20, 2012, from DEKA Research & Development Corp. requesting that FDA reclassify stair climbing wheelchairs (21 CFR 890.3890) from Class III to Class II. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted 3 to a sitting position. The device is intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a proposed order which, if made final, would reclassify stair-climbing wheelchairs as Class II subject to premarket notification (510(k)) and special controls. The petitioner has one stair-climbing wheelchair approved, the iBot (P020033), and it is indicated for the following: to provide indoor and outdoor mobility in confined spaces, at an elevated height, climb curbs, ascend/descend stairs, traverse obstacles, travel over a wider variety of terrain, and negotiate uneven/inclined surfaces. Stair-climbing wheelchairs are preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Stair-climbing wheelchairs are currently regulated as Class III devices. A call for premarket approval (PMA) applications was issued on April 13, 2000 (effective July 12, 2000) (65 FR 19834). The committee's discussion will include recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of stair-climbing wheelchairs. On December 12, 2013, during Session III, the committee will discuss and make recommendations regarding the possible reclassification of mechanical wheelchairs (21 CFR 890.3850) from Class I, currently subject to premarket notification (510(k)), to Class II, subject to special controls. The mechanical wheelchairs are being considered for exemption from premarket notification (510(k)) requirements. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted 4 to a sitting position. No proposed order has been issued for this proposed change in classification. Mechanical wheelchairs are preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Mechanical wheelchairs are currently regulated as Class I devices that are subject to premarket notification (510(k)) requirements (48 FR 53041). The committee will discuss whether general and/or special controls are appropriate to demonstrate a reasonable assurance of safety and effectiveness of mechanical wheelchairs and whether, if reclassified to Class II, these devices should be exempt from premarket notification (510(k)) requirements.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/24/13-7/25/13

Meeting Details:

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5- S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

 

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

Meeting Date: 4/5/13-4/5/13

Meeting Details:

On April 5, 2013, the committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy 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 requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378.

 

       
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 9/21/12-9/21/12

Meeting Details:

On September 21, 2012, the committee will discuss and make recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.

 

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

Meeting Date: 5/12/11-5/12/11

Meeting Details:

On May 12, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft.

 

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

Meeting Date: 7/27/10-7/27/10

Meeting Details:

On July 27, 2010, the committee will discuss, make recommendations and vote on a premarket approval application for the AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY rhBMP-2 Matrix is used for posterolateral fusion treatment of single level lumbar (L2S1) degenerative disc disease.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 3/23/10-3/23/10

Meeting Details:

On March 23, 2010, the committee will discuss and make recommendations on issues relevant to FDA's reevaluation of the ReGen Collagen Scaffold (CS) device (marketed as the Menaflex[reg]), which FDA cleared in K082079 on December 18, 2008, sponsored by ReGen Biologics, Inc. The indications for use statement for this device states that the device is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 11/4/09-11/4/09

Meeting Details:

On November 4, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Dynesys Spinal System, sponsored by Zimmer Spine. The Dynesys Spinal System is indicated to provide spinal alignment and stabilization in skeletally mature patients at one or two contiguous levels from L1-S1.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 8/18/09-8/19/09

Meeting Details:

On August 18, 2009, the committee will discuss, make recommendations and vote on a premarket approval application (PMA) for the CoMplete Acetabular Hip System, sponsored by DePuy Orthopaedics. This device system is intended for use as a primary joint replacement prosthesis in total hip arthroplasty, and is indicated for skeletally mature patients suffering severe pain and disability due to structural damage in the hip joint from non-inflammatory degenerative joint disease and its composite diagnoses of osteoarthritis or post-traumatic arthritis. On August 19, 2009, the committee will discuss, make recommendations and vote on a PMA for Durolane, sponsored by Q-Med AB. This device is indicated for the treatment of pain caused by osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics, e.g., acetaminophen.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 3/31/09-3/31/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for OP-1 Putty, sponsored by Stryker Biotech. This combination product is indicated for posterolateral spinal fusion procedures in skeletally mature patients with lumbar spondylolisthesis who have failed at least 6 months of conservative nonsurgical treatment.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/9/08-12/9/08

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for Synvisc-One, sponsored by Genzyme Corp. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

 

       
Location: Hilton GB, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 11/14/08-11/14/08

Meeting Details:

The committee will discuss and make recommendations on a premarket notification application for the ReGen Collagen Scaffold (CS), sponsored by ReGen Biologics, Inc. This device is intended for use in surgical procedures for the reinforcement and repair of chronic soft tissue injuries of the meniscus (one to three prior surgeries to the involved meniscus) where weakness exists. In repairing and reinforcing meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/15/08-7/15/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for Oxiplex/SP Gel, sponsored by FzioMed, Inc. This device is intended to be used as a surgical adjuvant during posterior lumbar laminectomy, larninotomy, or discectomy to improve patient outcomes by reducing postoperative leg pain, back pain, and neurological symptoms.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/17/07-7/17/07

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the Bryan Total Cervical Disc Prosthesis, sponsored by Medtronic Sofamor Danek, Inc. This device is indicated in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C3-C7. DDD is defined as any combination of the following: Disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 4/24/07-4/24/07

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for the Scandinavian Total Ankle Replacement System, sponsored by Link America, Inc. This system is intended for use as a noncemented implant to replace a painful arthritic and/or severely deformed ankle due to rheumatoid arthritis, primary arthrosis, or posttraumatic arthrosis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/22/07-2/22/07

Meeting Details:

On February 22, 2007, the committee will discuss, make recommendations and vote on a premarket approval application for the Cormet 2000 Hip Resurfacing System, sponsored by Corin U.S.A. This system is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with non- inflammatory degenerative arthritis or inflammatory arthritis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 9/19/06-9/19/06

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for a cervical disc prosthesis intended to treat skeletally mature patients with degenerative disc disease at one level from C3-C7.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 6/2/06-6/2/06

Meeting Details:

The committee will discuss and make a recommendation on the reclassification of the noninvasive bone growth stimulator indicated for the treatment of established nonunion fractures acquired secondary to trauma and as an adjunct to the treatment of lumbar spinal fusion surgery for one or two levels.

 

       
Location: Holiday Inn Related News Links: Not Available
Time: 8:30AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices Panel

Meeting Date: 9/8/05-9/9/05

Meeting Details:

On September 8, 2005, the committee will hear 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 hip joint metal/metal semi constrained resurfacing hybrid prosthesis (cemented femoral component). The device is intended to relieve hip pain and improve hip function in patients who have adequate bone stock and are at risk of requiring more than one hip joint replacement over their lifetimes. On September 9, 2005, the committee will discuss the design of clinical studies for spinal devices indicated for treatment of mild to moderate low back pain.

 

       
Location: Hilton Washington DC North Ballroom 620 Perry Pkwy. Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 8/31/04-8/31/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an interspinous process distraction system intended for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to mild or moderate lumbar spinal stenosis who have undergone a regimen of non-operative treatment.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 6/2/04-6/3/04

Meeting Details:

On June 2, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application for an artificial lumbar disc intended for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from L4-S1. On June 3, 2004, from 8 a.m. to 1 p.m., the committee will discuss, make recommendations and vote on a reclassification petition for total and unicompartmental mobile bearing knee joint prostheses. Also on June 3, 2004, from 1 p.m. to 5 p.m., the committee will discuss and make recommendations on a draft guidance document for clinical performance data requirements for hip joint prostheses.

 

       
Location: Gaithersburg Marriott Related News Links: Not Available
Time: 10:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/11/03-12/11/03

Meeting Details:

The committee will discuss, make recommendations, and vote on the reclassification of the intervertebral body fusion device (cage) intended for spinal fusion procedures in skeletally mature adults with degenerative disc disease at one or two levels from C2-C7 and L2-S1 using autogenous bone graft. The device does not include combination products, such as the intervertebral body fusion device using morphogenic proteins and scaffolds.

 

       
Location: Holiday Inn GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 11/20/02-11/21/02

Meeting Details:

On November 20, 2002, the committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a stair-climbing wheelchair. On November 21, 2002, the committee will discuss, make recommendations, and vote on a PMA for growth factors soaked in a collagen sponge used to treat tibial fractures. In addition, on November 21, 2002, the committee will have a general discussion on preclinical and clinical data for spinal devices.

 

       
Location: Holiday Inn, Walker/Whetstone Rooms Two Montgomery Village Ave. Gaithersburg , MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 8/8/01-8/9/01

Meeting Details:

The committee will discuss and make recommendations on the reclassification of metal on metal total hip arthroplasty devices. Also, the committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a metacarpophalangeal finger joint prosthesis.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices Panel

Meeting Date: 1/19/01-1/19/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a cervical interbody fusion system.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices

Meeting Date: 7/20/00-7/20/00

Meeting Details:

The committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a shock wave lithotriptor used for the treatment of heel pain and a PMA for a ceramic on ceramic total hip arthroplasty.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices Panel

Meeting Date: 11/4/99-11/5/99

Meeting Details:

On November 4th, the committee will discuss and make recommendations on the reclassification of constrained total hip arthroplasty devices. The committee will also discuss the development of computer controlled surgical systems designed for use in orthopedic procedures. On November 5th, the committee will discuss post-marketing studies of Genzyme Corporation's Carticel (autologous chondrocytes manipulated ex-vivo for structural repair) indicated for treatment and repair of clinically significant, articular cartilage defects in the knee. The discussion will focus on issues specific to these studies and on more general ones related to the feasibility of randomized controlled trials in the field of orthopedics.

 

       
Location: Corporate Bldg. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices

Meeting Date: 10/8/98-10/9/98

Meeting Details:

On October 8, 1998, the committee will consider issues relating to the study and evaluation of spinal device assemblies. In the context of a preliminary background document, the committee will be asked to address scientific issues pertaining to the development of investigational device exemptions (IDE) applications for spinal device assemblies. This will include inclusion/exclusion criteria, type of control(s), study endpoints, and length of follow-up.

 

       
Location: Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices

Meeting Date: 4/27/98-4/28/98

Meeting Details:

April 27, 1998 Panel Training - Conflict of Intrest. General and PDP training. Reclassification training. April 28, 1998 Reclassification of bone cement.

 

       
Location: FDA 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 OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/18/16-2/18/16

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Meeting Details:

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.

 

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

Meeting Date: 2/19/16-2/19/16

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Meeting Details:

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Amended: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

 

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

Meeting Date: 2/25/16-2/26/16

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Meeting Details:

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for ``TOPAS Treatment for Fecal Incontinence,' by ASTORA Women's Health, LLC. The ``TOPAS Treatment for Fecal Incontinence' device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the ``TOPAS Treatment for Fecal Incontinence' device, as stated in the PMA, is as follows: The ``TOPAS Treatment for Fecal Incontinence' is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows: OTN and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAG and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAH and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;' OTO and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' PAJ and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' OTP and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed' and PAI and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.' Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: Urogynecologic surgical mesh instrumentation is used: [cir] IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code ``LKX' and the associated device classification name, ``Device, Thermal, Hemorrhoids.' The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). [cir] IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. [cir] IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. [cir] IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code ``LRL' and the associated device classification name, ``Cushion, Hemorrhoid.' The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). [cir] IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. [cir] IFU/IU: Intended for the home convalescent patient with perineal discomfort. Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts ``slight' pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code ``LKN' and the associated device classification name, ``Separator, automated, blood cell and plasma, therapeutic.' The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments [[Page 940]] became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. Uses continuous flow access to a rotating centrifuge to separate blood components. [cir] IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. [cir] IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

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Meeting Details:

On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/15/16-3/16/16

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Meeting Details:

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length = 24 millimeters (mm)) with a reference vessel diameter of = 2.5 mm and = 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/3/16-2/3/16

Meeting Details:

During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 1/21/16-1/21/16

Meeting Details:

The committees will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm - PROBUPHINE

Meeting Date: 1/12/16-1/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence.

 

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

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Past Meetings

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