AGENDA

  CIRCULATORY SYSTEM DEVICES PANEL

 April 21, 2004

                     

Gaithersburg Marriott, 9751 Washingtonian Blvd., Salons E, F & G of the Ballroom,  Gaithersburg, MD.

 

9:00 a.m.                        Call to Order                         Warren Laskey, M.D.

                                                                        Chairperson

9:05 – 9:30  a.m.                        *Open Public Session*

 

9:30 – 10:45 a.m.                         Sponsor Presentation:  Cordis Corporation

P030047: Cordis Precise Nitinol Stent System

 

10:45 – 11:00 a.m.                        Questions and Answers

 

11:00 – 11:15 a.m.                        Break

 

11:15 – 12:15 a.m.                        FDA Presentation

 

12:15 – 12:30 p.m.                        Questions and Answers

 

12:30 p.m.       Adjourn – Break for Lunch

 

1:30 – 2:15 p.m.                            Call to Order                                 

 

2:15 – 3:45 p.m.                        Open Committee Discussion                        Warren Laskey, M.D.

 

3:45 – 4:00 p.m.                            Break

 

4:00 – 5:00 p.m.                                  *Open Public Session*

                            FDA Comments

                        Sponsor Comments

                        Recommendations & Vote                           Warren Laskey, 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. Laskey will recognize unscheduled speakers as time allows.

 

Note: Only the Chair and members of the Panel may question speakers during the open public hearing.