CIRCULATORY SYSTEM DEVICES PANEL
November 20, 2003
Hilton Gaithersburg Washington D.C./North, Salons C, D & E, 620 Perry Parkway, Gaithersburg, MD.
9:00 a.m. Call to Order Warren K. Laskey, M.D.
9:05 – 9:35 a.m. *Open Public Session*
9:30 – 10:30 a.m. Sponsor Presentation: Spectranetics Corporation
P910001/S022: Spectranetics CVX-300 Excimer Laser System
10:30 – 10:45 a.m. Questions and Answers
10:45 – 11:00 a.m. Break
11:00 – 12:00 p.m. FDA Presentation
12:00 – 12:15 p.m. Questions and Answers
12:15 p.m. Adjourn – Break for Lunch
1:15 – 2:15 p.m. Call to Order
2:15 – 3:15 p.m. Open Committee Discussion Warren K. Laskey, M.D.
3:15 – 3:30 p.m. Break
3:30 – 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.