AGENDA
CIRCULATORY
SYSTEM DEVICES PANEL
June 8, 2004
Hilton Washington DC North/Gaithersburg, Salons A, B,
and C, 620 Perry Parkway, Gaithersburg, MD.
8:00 – 5:00 PMA Discussion, Recommendations, and
Voting
8:00 a.m. Call
to Order Warren
Laskey, M.D.
Chairperson
8:05 – 8:30 a.m. *Open Public Session*
8:30 – 9:30 a.m. Sponsor
Presentation: World Heart
P0980012/S004: Novacor N100PC and
N100PC(q) Left Ventricular Assist System (LVAS)
9:30 – 9:45 a.m. Questions
and Answers
9:45 – 10:00 a.m. Break
10:00 – 11:00 a.m. FDA Presentation
11:00 – 11:15 a.m. Questions
and Answers
11:15 – 12:00 p.m. Open
Committee Discussion Warren
Laskey, M.D.
12:00 p.m. Adjourn – Break
for Lunch
1:00 – 1:15
p.m. Call to
Order
1:15 – 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.