March 17, 2003

Hilton Gaithersburg Washington D.C./North, Salons A, B & C, 620 Perry Parkway, Gaithersburg, MD.

9:00 5:00 PMA Discussion, Recommendations, and Voting


9:00 a.m. Call to Order Cynthia Tracy, M.D.

Acting Chairperson


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*

FDA Comments

Sponsor Comments

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.