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