CIRCULATORY SYSTEM DEVICES PANEL
May 29, 2003
Gaithersburg Holiday Inn, Walker/Whetstone room, 2 Montgomery Village Avenue, Gaithersburg, MD
9:00 a.m. Call to Order Warren K. Laskey, M.D., Acting Chairperson
9:05 9:30a.m. Office of Surveillance and Biometrics Presentation
Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
Marian Kroen, OSB/Issues Management Staff
9:30 10:00 a.m. *Open Public Session*
10:00 11:00 a.m. Sponsor Presentation: Cardima, Inc.
P020039, Revelation Tx & NavAblator Catheter System
11:00 11:15 a.m. Questions and Answers
11:15 11:30 a.m. Break
11:30 12:30 p.m. FDA Presentation
12:30 12:45 p.m. Questions and Answers
12:45 p.m. Adjourn Break for Lunch
1:45 2:45 p.m. Call to Order
2:45 3:45 p.m. Open Committee Discussion Warren K. Laskey, M.D.
3:45 4:00 p.m. Break
4:00 5:00 p.m. *Open Public Session*
Recommendations & Vote Warren K. Laskey, M.D.
5:00 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. 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.