CIRCULATORY SYSTEM DEVICES PANEL
July 29, 2004
Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.
9:00 a.m. Call to Order Warren Laskey, M.D.
9:05 – 9:30 a.m. Office of Surveillance and Biometrics Presentation
"Adverse Event Reports on Automatic External Defibrillators from 1996 - 2003"
Oscar H. Tovar, M.D., OSB/ODE
9:30 – 10:00 a.m. *Open Public Session*
10:00 – 11:15 a.m. Sponsor Presentation: Philips Medical
K040904: HeartStart Home
11:15 – 11:30 a.m. Questions and Answers
11:30 – 11:45 a.m. Break
11:45 – 12:45 p.m. FDA Presentation
12:45 – 1:00 p.m. Questions and Answers
1:00 p.m. Adjourn – Break for Lunch
2:00 p.m. Call to Order
2:00 – 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*
Recommendations & Vote Warren Laskey, M.D.
5:00 p.m. Adjourn
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.