CIRCULATORY SYSTEM DEVICES PANEL
March 5, 2001
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD
8:00 – 3:00pm PMA Discussion, Recommendations, and Voting
8:00 a.m. Call to Order Warren Laskey, M.D., Acting Chairperson
8:05 – 8:15 a.m.* Open Public Hearing*
8:15 – 9:15 a.m. Sponsor Presentation: Medtronic Corporation
P010031, Medtronic® InSync ICD® System Model 7272
William T. Abraham M.D., University of Kentucky
James B. Young, M.D., Cleveland Clinic Foundation
Angel R. Leon, M.D., Emory University
9:15 – 10:15 a.m. FDA Presentation
Doris Terry, lead reviewer
Helen S. Barold, M.D., clinical reviewer
Gerry Gray, Ph.D., statistical reviewer
10:15 – 10:30 a.m. Break
10:30 a.m. – 12:00 p.m. Open Committee Discussion Warren Laskey, M.D.
12:00 p.m. Adjourn – Break for Lunch
1:00 p.m. Call to Order , Open Committee Discussion, Warren Laskey, M.D.
Recommendations and Voting
2:45 – 3:00 p.m.* Open Public Hearing*
3:00 p.m. Adjourn
OPEN PUBLIC HEARINGS*
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Dr. Ewing will present the speakers who have requested time for presentation to the Panel. After the scheduled speakers have spoken, the Chair may ask them to remain if the committee wishes to question them further. Dr. Laskey will recognize unscheduled speakers as time allows.
Note: Only the Chair and members of the Panel may question speakers during the open public hearing.