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

 

 

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. 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.