AGENDA

CIRCULATORY SYSTEM DEVICES PANEL

March 18, 2004

Hilton Gaithersburg Washington D.C./North, Salons A, B & C, 620 Perry Parkway, Gaithersburg, MD.

9:00 5:00 PMA Discussion and Recommendations

 

9:00 a.m. Call to Order William H. Maisel, M.D., M.P.H.

Acting Chairperson

9:05 10:05 a.m. FDA Presentation

Data requirements for CPR devices

10:05 10:15 a.m. Questions

 

10:15 10:45 a.m. *Open Public Session*

 

10:45 11:00 a.m. Break

 

11:00 12:30 p.m. Open Committee Discussion William H. Maisel, M.D., M.P.H.

FDA Questions & Panel Recommendations Acting Chairperson

 

 

12:30 p.m. Adjourn Break for Lunch

 

1:30 1:45 p.m. Call to Order

 

1:45 2:45 p.m. FDA Presentation

Hypothermia Devices

2:45 3:00 p.m. Questions

 

3:00 3:30 p.m. *Open Public Session*

 

3:30 3:45 p.m. Break

 

3:45 5:00 p.m. Open Committee Discussion William H. Maisel, M.D., M.P.H.

FDA Questions & Panel Recommendations Acting Chairperson

 

5:00 p.m. Adjourn

 

 

OPEN PUBLIC HEARINGS*

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.