CIRCULATORY SYSTEM DEVICES PANEL
March 17, 2005
Hilton Washington DC North/Gaithersburg, Crystals Ballroom, 620 Perry Parkway, Gaithersburg, MD.
8:00 a.m. Call to Order William H. Maisel, M.D., M.P.H.
8:05 – 8:35 a.m. *Open Public Session*
8:35 – 9:35 a.m. Sponsor Presentation: Alsius Corporation
K040429: CoolGard 3000/Icy Heat Exchange Catheter Thermal Regulating System
9:35 – 9:50 a.m. Questions and Answers
9:50 – 10:50 a.m. FDA Presentation
10:50 – 11:05 a.m. Questions and Answers
11:05 – 11:20 a.m. Break
11:20 – 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*
Recommendations & Vote 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.