AGENDA

CIRCULATORY SYSTEM DEVICES PANEL

March 6, 2003

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

 

10:30 5:30 PMA Discussion, Recommendations, and Voting

 

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.