AGENDA

  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.

                                                                        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

 

 

OPEN PUBLIC HEARINGS*

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.