DRAFT OPEN SESSION AGENDA

 NEUROLOGICAL DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

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