AGENDA
CIRCULATORY
SYSTEM DEVICES PANEL
June 23, 2005
Hilton Washington DC North/Gaithersburg, Crystals
Ballroom, 620 Perry Parkway, Gaithersburg, MD.
8:00 – 4:30 HDE Discussion and Recommendations
8:00 a.m. Call
to Order William
H. Maisel, M.D., M.P.H.
Chairperson
8:05 Special
Presentation Bram
Zuckerman, M.D.
Division Director, DCD
8:10 – 8:40 a.m. *Open Public
Session*
8:40 – 9:40a.m. Sponsor
Presentation: Abiomed, Inc.
H040006: Abiocor
Implantable Replacement Heart
9:40 – 9:55 a.m. Questions
and Answers
9:55 – 10:10 a.m. Break
10:10 – 11:10
a.m. FDA
Presentation
11:10 – 11:25 a.m. Questions
and Answers
11:25 – 12:30 p.m. Open
Committee Discussion
12:30 p.m. Adjourn
– Break for Lunch
1:30 p.m. Call to Order
1:30 – 3:00 p.m. Open
Committee Discussion William
H. Maisel, M.D., M.P.H.
3:00 – 4:00
p.m. *Open Public Session*
FDA Comments
Sponsor
Comments
Recommendations William H. Maisel, M.D.,
M.P.H.
4:00 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. Maisel will recognize unscheduled
speakers as time allows.
Note: Only the Chair and members of the Panel may
question speakers during the open public hearing.