NEUROLOGICAL DEVICES PANEL
Two Montgomery Village Avenue
June 15, 2004
Panel Chairperson Executive Secretary
Kyra J. Becker, M.D. Janet L. Scudiero, M.S.
8:00 am Call to Order
Update since the February 23, 2004 Meeting
Theodore R. Stevens, Chief, Restorative Devices Branch (REDB)
Cyberonics, Inc., Implanted Vagus Nerve Stimulation System,
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.