AGENDA

  CIRCULATORY SYSTEM DEVICES PANEL

 July 28, 2004

Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.

 

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

                                                                        Acting Chairperson

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

 

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

P010012/S26: Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

 

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

 

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

 

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

 

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

 

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

 

1:30 p.m.                            Call to Order                                 

 

1:30 – 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.