NEUROLOGICAL DEVICES PANEL
Hilton Washington, D.C. North
620 Perry Parkway
June 17, 2005
Panel Chairperson Executive Secretary
Stephen J. Haines, M.D. Janet L. Scudiero, M.S.
8:30 am Call to Order
Critical Path Initiative, Sousan S. Altaie, Ph.D.
Postmarket Study Design, Susan N. Gardner, Ph.D.
Division Update, Theodore R. Stevens, M.S.
Olympic Medical Corporation, Olympic Cool-Cap®, PMA P040025
9:15 am 1st Open Public Hearing*
9:45 am Sponsor Presentation
Edward B. Weiler, Ph.D., Vice President, Research & Development. Seattle,WA
John S. Wyatt, M.D., University College Hospital, London, England
Ping-Yu Liu, Ph.D., Drug & Device Development Co., Inc., Redmond, WA
10:45 am Break
11:00 am FDA Presentation
Kristen A. Bowsher, Ph.D.
Susan K. McCune, M.D.
Jianxiong Chu, Ph.D.
12:00 m Lunch
1:00 pm Deliberations
Reese M. Clark, MD
3:30 pm Break
3:45 pm FDA and Sponsor Summations, up to 15 minutes each
4:15 pm Panel Vote
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.