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