Sixty-Eighth Meeting of the

Obstetrics and Gynecology Devices Panel

 

Thursday, June 3, 2004

Holiday Inn, Gaithersburg, Maryland

 

InSightec ExAblate^® 2000 (P040003)

 

DRAFT Agenda

 

 

8:30-8:45                        Introductory remarks

·        Colin Pollard, Chief, Obstetrics and Gynecology Devices Branch

 

8:45-9:15                        Open public hearing

 

9:15-10:30                        Presentation by Sponsor

 

10:30-10:45                        Break

 

10:45-12:00                        Presentation by FDA

§         Kathryn S. Daws-Kopp:  Overview of FDA Review

§         Julia A. Corrado, M.D.:  Clinical Review

§         Loren Zaremba, Ph.D.:  Magnetic Resonance

§         Bruce A. Herman, Ph.D.:  Ultrasound

§         Noel del Mundo, M.D.:  Adverse Events

 

12:00-1:00                        Lunch

 

1:00-2:45                        Panel discussion

 

2:45-3:00                        Break

 

3:00-3:30                        Open public hearing

 

3:30-4:30                        Panel deliberations and vote

 

4:30                        Adjourn