CIRCULATORY SYSTEM DEVICES PANEL
April 22, 2005
Holiday Inn, Walker/Whetstone Room, Two Montgomery Village Ave., Gaithersburg, MD.
8:00 a.m. Call to Order William H. Maisel, M.D., M.P.H.
8:05 8:20 a.m. FDA Presentation: Condition of Approval Studies: Recent Changes in CDRH
Susan Gardner, PhD; Director, Office of Surveillance and Biometrics
8:20 8:35 a.m. FDA Presentation: Panel update
David Buckles, PhD, FACC; Branch Chief, Peripheral Vascular Devices Branch
8:35 9:05 a.m. *Open Public Session*
9:05 10:05 a.m. Sponsor Presentation: Cardica Inc.
K030434: Cardica PAS-Port System
10:05 10:20 a.m. Questions and Answers
10:20 10:35 a.m. Break
10:35 11:35 a.m. FDA Presentation
11:35 11:50 a.m. Questions and Answers
11:50 12:30 p.m. Open Committee Discussion
12:30 p.m. Adjourn Break for Lunch
1:30 p.m. Call to Order
1:30 3:00 p.m. Open Committee Discussion William H. Maisel, M.D., M.P.H.
3:00 4:00 p.m. *Open Public Session*
Recommendations William H. Maisel, M.D., M.P.H.
4:00 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. Maisel will recognize unscheduled speakers as time allows.
Note: Only the Chair and members of the Panel may question speakers during the open public hearing.