AGENDA
CIRCULATORY
SYSTEM DEVICES PANEL
March 17, 2005
Hilton Washington DC North/Gaithersburg, Crystals
Ballroom, 620 Perry Parkway, Gaithersburg, MD.
8:00 – 4:00 510(k) Discussion and Recommendations
8:00 a.m. Call
to Order William
H. Maisel, M.D., M.P.H.
Chairperson
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*
FDA Comments
Sponsor
Comments
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.