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.



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.