AGENDA

CIRCULATORY SYSTEM DEVICES PANEL

March 5, 2001

Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD

8:00 3:00pm PMA Discussion, Recommendations, and Voting

8:00 a.m. Call to Order Warren Laskey, M.D., Acting Chairperson

8:05 8:15 a.m.* Open Public Hearing*

8:15 9:15 a.m. Sponsor Presentation: Medtronic Corporation

P010031, Medtronic® InSync ICD® System Model 7272

William T. Abraham M.D., University of Kentucky

James B. Young, M.D., Cleveland Clinic Foundation

Angel R. Leon, M.D., Emory University

9:15 10:15 a.m. FDA Presentation

Doris Terry, lead reviewer

Helen S. Barold, M.D., clinical reviewer

Gerry Gray, Ph.D., statistical reviewer

10:15 10:30 a.m. Break

10:30 a.m. 12:00 p.m. Open Committee Discussion Warren Laskey, M.D.

12:00 p.m. Adjourn Break for Lunch

 1:00 p.m. Call to Order , Open Committee Discussion, Warren Laskey, M.D.

Recommendations and Voting

2:45 3:00 p.m.* Open Public Hearing*

3:00 p.m. Adjourn

 

OPEN PUBLIC HEARINGS*

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Dr. Ewing 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. Laskey will recognize unscheduled speakers as time allows.

Note: Only the Chair and members of the Panel may question speakers during the open public hearing.