of the



Sixteenth Meeting


Hilton Washington North/Gaithersburg

Ballroom Salons, A, B, C, and D

620 Perry Parkway

Gaithersburg, Maryland

February 23, 2003


Panel Chairperson, acting Executive Secretary

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


9:30 am Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

Panel Introductions

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