AGENDA

  CIRCULATORY SYSTEM DEVICES PANEL

 May 29, 2003

                     

Gaithersburg Holiday Inn, Walker/Whetstone room, 2 Montgomery Village Avenue, Gaithersburg, MD     

9:00 – 5:00     PMA Discussion, Recommendations, and Voting

 

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

 

9:05 – 9:30a.m.                        Office of Surveillance and Biometrics Presentation

                        “Diathermy Interactions with Implanted Leads and Implanted Systems with Leads”

                        Marian Kroen, OSB/Issues Management Staff

 

9:30 – 10:00 a.m.                         *Open Public Session*

 

10:00 – 11:00 a.m.            Sponsor Presentation:  Cardima, Inc.

                        P020039, Revelation Tx & NavAblator Catheter System

 

11:00 – 11:15 a.m.                        Questions and Answers

 

11:15 – 11:30 a.m.                        Break

                       

11:30 – 12:30 p.m.                        FDA Presentation

 

12:30 – 12:45 p.m.                        Questions and Answers

 

12:45 p.m.       Adjourn – Break for Lunch

 

1:45 – 2:45 p.m.                            Call to Order                                 

 

2:45 – 3:45 p.m.                            Open Committee Discussion                                      Warren K. 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 K. 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.