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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/27/15-2/27/15

Meeting Details:

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows: The Radiesse device is for hand augmentation to correct volume deficit in the hands. FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

 

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

Meeting Date: 6/26/13-6/26/13

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

 

       
Location: Holiday Inn Gaithersburg, MD 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: 5/2/13-5/2/13

Meeting Details:

On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juv[eacute]derm Voluma XC sponsored by Allergan, Inc. Juv[eacute]derm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juv[eacute]derm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/ supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/21/12-6/21/12

Meeting Details:

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the Medical Devices

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

Meeting Details:

On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in mid-to-deep subdermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/30/11-8/31/11

Meeting Details:

On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 4/27/11-4/27/11

Meeting Details:

On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/10-11/18/10

Meeting Details:

On November 18, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for MelaFind, sponsored by MELA Sciences. MelaFind(R) is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ``ugly duckling'') cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/10-3/25/10

Meeting Details:

On March 25, 2010, the committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer (both melanoma and non-melanoma). The committee will be asked to recommend whether changes to current classification or current regulatory controls of UV emitting devices (lamps) used for tanning are needed.

 

       
Location: Hilton Gaithersburg MD 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: 11/18/08-11/19/08

Meeting Details:

On November 18, 2008, the committee will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers. In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses. On November 19, 2008, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will make recommendations on how to quantify the effects of devices with various types of energy sources, such as light-based products, light-based combination devices, ultrasound devices (including focused ultrasound devices), massagers combined with other energy modalities, cryogenic energy devices, radiofrequency ablation devices, and microwave systems, on dermatologic conditions.

 

       
Location: Rio Gaithersburg, MD 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: 8/24/06-8/25/06

Meeting Details:

On August 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: cyanoacrylate tissue adhesive.

 

       
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: 8/25/05-8/26/05

Meeting Details:

On August 25, 2005, 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. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsInamed & Mentor - General & Plastic Surgery

Meeting Date: 4/11/05-4/13/05

Meeting Details:

On April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Related Link From Inamed. Also Mentor will be presenting: Related Link From Yahoo

 

       
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: 5/12/04-5/12/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an in situ polymerizable sealant material intended to be used to seal air leaks following pulmonary surgery.

 

       
Location: Holiday Inn, GB 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: 3/25/04-3/25/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients.

 

       
Location: Hilton Washington 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: 11/21/03-11/21/03

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications (PMAs) for injectable devices intended to restore soft tissue facial contours such as nasolabial folds.

 

       
Location: HOL Gaithersburg , MD 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: 10/14/03-10/15/03

Meeting Details:

On October 14 and 15, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for Silicone Gel-Filled Breast Prostheses.

 

       
Location: Marriott Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-10:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/24/03-7/24/03

Meeting Details:

The committee will discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. There will also be a discussion of a general issue: clinical trial issues for devices designed for percutaneous removal of breast tumors.

 

       
Location: Hilton - GB 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: 2/28/03-2/28/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an injectable wrinkle treatment device. There will also be a discussion of two general issues: (1) clinical trial issues for devices designed for ablation of pulmonary tumors, and 2) clinical trial issues for devices designed for the treatment of emphysema.

 

       
Location: Hilton Gaithersburg , MD 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: 7/8/02-7/9/02

Meeting Details:

On July 8, 2002, the committee will discuss and make recommendations on the classification of a preamendment device, the silicone elastomer for scar management. The committee will also discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. On July 9, 2002, the FDA and two manufacturers of approved saline inflatable breast implant devices will present postmarket information to the committee for their consideration.

 

       
Location: Holiday Inn Gaithersburg, MD 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: 7/17/01-7/17/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Interactive Wound and Burn Dressing.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 5/8/00-5/8/00

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications: 1) for an in situ polymerizable surgical mesh intended to be used to seal air leaks following thoracic cavity surgery; and 2) for an interactive wound and burn dressing intended to be used for the treatment of diabetic foot ulcers by FocalSeal.

 

       
Location: Gaithersburg Marriott Washingtonian Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 3/1/00-3/3/00

Meeting Details:

On March 1, 2000, there will be a brief FDA presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997. Also on March 1, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for Saline Inflatable Breast Prostheses. On March 2, 2000, the committee will discuss, make recommendations and vote on two PMAs for Saline Inflatable Breast Prostheses. On March 3, 2000, the committee will discuss content, format, and consistency issues involving the labeling information provided to patients considering saline-filled breast prostheses.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 1/12/00-1/12/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Absorbable Adhesion Barrier Device.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 8/2/99-8/2/99

Meeting Details:

The committee will discuss possible revisions to the 1995 draft guidance

 

       
Location: Corporate Bldg., conference room 020B, 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 6/16/99-6/16/99

Meeting Details:

On June 16, 1999, the committee will discuss, make recommendations and vote on premarket approval application for computer-guided surgical instruments for use in endoscopic surgery. *** 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 OptionsGeneral & Plastic Surgery Devices

Meeting Date: 11/17/98-11/17/98

Meeting Details:

The committee will discuss and make recommendations on a proposal for the classification of preamendment wound dressing medical devices based on: 1) a proposed rule published in the Federal Register of September 19, 1989 (54 FR 38600); 2) comments received in response to the proposed rule; and 3)comments from the General and Plastic Surgery Devices Panel Meeting of July 20, 1995. The committee will also discuss and make recommendations on the reclassification of preamendment class III topical oxygen devices for woundhealing on extremities based on information received from a call for safety and effectiveness information under section 515(I) published in the Federal Registers of August 14, 1995 and June 13, 1997 (60 FR 41986 and 62 FR 32355, respectively).

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

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

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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 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    
Materials:
   
       

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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 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    
Materials:
   
       

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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    
Materials:
   
       

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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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