CIRCULATORY SYSTEM DEVICES PANEL
March 17, 2003
Hilton Gaithersburg Washington D.C./North, Salons A, B & C, 620 Perry Parkway, Gaithersburg, MD.
9:00 a.m. Call to Order Cynthia Tracy, M.D.
9:05 – 9:30 a.m. *Open Public Session*
9:30 – 10:30 a.m. Sponsor Presentation: Syncardia Systems, Inc.
P030011: Syncardia Systems CardioWest Total Artificial Heart
10:30 – 10:45 a.m. Questions and Answers
10:45 – 11:00 a.m. Break
11:00 – 12:00 a.m. FDA Presentation
12:00 – 12:15 p.m. Questions and Answers
12:15 p.m. Adjourn – Break for Lunch
1:15 – 2:15 p.m. Call to Order
2:15 – 3:45 p.m. Open Committee Discussion Cynthia Tracy, M.D.
3:45 – 4:00 p.m. Break
4:00 – 5:00 p.m. *Open Public Session*
Recommendations & Vote Cynthia Tracy, M.D.
5:00 p.m. Adjourn
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Ms. Wood 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. Tracy will recognize unscheduled speakers as time allows.
Note: Only the Chair and members of the Panel may question speakers during the open public hearing.