CIRCULATORY SYSTEM DEVICES PANEL
March 4, 2002
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD
10:00 4:00 PMA Supplement Discussion, Recommendations, and Voting
10:00 a.m. Call to Order Warren Laskey, M.D., Acting Chairperson
10:05 10:15 a.m.* Open Public Hearing*
10:15 11:15 a.m. Sponsor Presentation: Thoratec Corporation
P910014/S016, HeartMate VE LVAS
Donald A. Middlebrook, Vice President Regulatory Affairs and Quality Assurance
Victor Poirier, Chief Technology Advisor
Eric Rose, MD, REMATCH Principal Investigator, Chairman Department
of Surgery Columbia-Presbyterian Medical Center, NY
Lynne W. Stevenson MD, REMATCH Medical Management Committee
Chair & Director Cardiomyopathy and Heart Failure Brigham &Womans Hospital, Boston
11:15 12:00 p.m. FDA Presentation
Michael Berman, PhD, lead reviewer
Julie Swain, MD, clinical reviewer
12:00 p.m. Adjourn Break for Lunch
1:00 p.m. Call to Order : Open Discussion Warren Laskey, M.D.
2:15 2:30 p.m. Break
2:30 3:15 p.m. Open Panel Discussion, Recommendations Warren Laskey, M.D.
3:45 4:00 p.m. Open Public Hearing*
4:15 5:00 p.m. Closed session***
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.
The session will be closed to the public from 4:15-5:00p.m., in order to allow the Panel to hear trade secret and/or confidential information.