AGENDA

CIRCULATORY SYSTEM DEVICES PANEL

July 28, 2004

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

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

 

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.