AGENDA
CIRCULATORY
SYSTEM DEVICES PANEL
November 20, 2003
Hilton Gaithersburg
Washington D.C./North, Salons C, D & E, 620 Perry Parkway, Gaithersburg,
MD.
9:00 – 5:00 PMA Discussion, Recommendations, and
Voting
9:00 a.m. Call
to Order Warren K.
Laskey, M.D.
Acting Chairperson
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*
FDA Comments
Sponsor
Comments
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.