NEUROLOGICAL DEVICES PANEL
620 Perry Parkway
February 23, 2003
Panel Chairperson, acting Executive Secretary
Kyra J. Becker, M.D. Janet L. Scudiero, M.S.
9:30 am Call to Order
Update Since the August 5, 2003 Meeting
Neil R. Ogden, Chief, General Surgery Devices Branch
9:45 am Open Public Hearing*, up to 60 minutes
10:45 am Concentric Medical MERCI 510(k) K03-3736
Kevin F. MacDonald, Vice President Clinical and Regulatory Affairs
Gene Sung, MD, MPH, Director, Neurocritical Care and Stroke Program, USC
Wade Smith, MD, PhD, Director, Neurovascular Service, UCSF
Gary Duckwiler, MD, Professor of Radiology, UCLA
11:45 am FDA Presentation
Clinical Review: Michael Schlosser, M.D.
Statistical Review: Judy S. Chen, M.S.
12:45 pm Lunch
1:30 am Panel Deliberations
Clinical Review: Mary E. Jensen, M.D.
Statistical Review: Jonas H. Ellenberg, Ph.D.
2:30 pm Break
2:45 pm FDA and Sponsor Summations, up to 15 minutes each
3:15 pm FDA Questions and Concluding Comments
5:00 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