NEUROLOGICAL DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

Seventeenth  Meeting

Holiday Inn

 Walker/Whetstone Rooms

Two Montgomery Village Avenue

 Gaithersburg, Maryland

June 15, 2004

 

Panel Chairperson                                                                                                          Executive Secretary

Kyra J. Becker, M.D.                                                                                       Janet L. Scudiero, M.S.

 

 8:00        am                Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

                                Panel Introductions

                                Update since the February 23, 2004 Meeting

Theodore R. Stevens, Chief, Restorative Devices Branch (REDB)

                                                                 

Cyberonics, Inc., Implanted Vagus Nerve Stimulation System,

PMA P970003/S50

 

 8:15        am                1st Open Public Hearing*

                               

 9:45        am                Sponsor Presentation

                                                Alan Totah, Vice President of Regulatory Affairs, Cyberonics, Inc.

A. John, Rush, M.D., University of Texas Southwestern, Dallas, TX

Richard L. Rudolph, M.D., Vice President of Clinical and Medical

                Affairs and Chief Medical Officer, Cyberonics, Inc.

 

11:15       am                 Break

 

11:30       am                FDA Presentation                                                         

                                                Carlos L. Peña, Ph.D.

Michael J. Schlosser, M.D.

                                                Chang S. Lao, Ph.D., Division of Biostatistics

 

12:30       pm                Lunch

                                               

 1:30        pm                Panel Deliberations

                                                Philip S. Wang, M.D., M.P.H., Dr. P.H.

                                                Jonas H. Ellenberg, Ph.D.

 

 3:45        pm                2nd Open Public Hearing*

 

 4:15        pm                Break

 

 4:30        pm                FDA and Sponsor Summations, up to 15 minutes each                                                                 

                                               

 5:00        pm                Panel Vote  

 

 6:00        pm                Adjournment                      

 

* Open Public Hearings – Interested persons may present data, information, or views, orally or in writing, on the issue pending before the panel.  Scheduled speakers who have requested time to address the panel will speak at this time.  After they have spoken, the Chair may ask them to remain if the panel wishes to question them. Then the Chair will recognize unscheduled speakers as time allows.  Only the panel may question speakers during the open public hearing.