AGENDA
CIRCULATORY
SYSTEM DEVICES PANEL
July 29, 2004
Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg,
MD.
9:00 – 5:00 510(k) Discussion and Recommendations
9:00 a.m. Call
to Order Warren
Laskey, M.D.
Acting Chairperson
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*
FDA Comments
Sponsor
Comments
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.