April 22, 2005

Holiday Inn, Walker/Whetstone Rooms, Two Montgomery Village Ave., Gaithersburg, MD.

8:00 – 4:30     510(k) Discussion and Recommendations


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*

                            FDA Comments

                        Sponsor Comments

                        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.