AGENDA

  CIRCULATORY SYSTEM DEVICES PANEL

 March 6, 2003

                     

Gaithersburg Marriott, Salons A, B, and C, 9751 Washingtonian Blvd., Gaithersburg, MD.

 

                       

 

10:30 a.m.                        Call to Order                         Warren K. Laskey, M.D., Acting Chairperson

 

10:35 – 11:00 a.m.*                        Open Public Session*

 

11:00 – 12:00 noon                        Sponsor Presentation:  Cryocath Technologies, Inc.

                        P020045, 7F Freezor Cardiac Cryoablation Catheter

 

12:00 – 1:00 p.m.                        FDA Presentation

 

 

 

1:00 – 2:00 p.m.                 Adjourn – Break for Lunch

 

 

2:00 – 2:15 p.m.                            Questions and Answers

 

2:15 – 3:30 p.m.                            Open Committee Discussion                                      Warren K. Laskey, M.D.

 

3:30 – 3:45 p.m.                        Break

 

3:45 – 5:30 p.m.                                  *Open Public Session*

                            FDA Comments

                        Sponsor Comments

                        Recommendations & Vote                               Warren K. Laskey, M.D.

 

5:30 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.