Sixty-Fifth Meeting of the

Obstetrics and Gynecology Devices Panel

 Monday, April 22, 2002
Gaithersburg Marriott

Neoventa STAN^Ò S21 Fetal Heart Monitor (P020001)

 8:00-8:30                        Introductory remarks

·        Colin Pollard, Chief, Obstetrics and Gynecology Devices Branch

8:30-9:00                        Open public hearing

9:00-10:10                        Presentation by Sponsor

·        Dr. K.G. Rosen:  Overview of STAN concept and SRCT

·        Karel Marsel and Ingemar Kjellmar:  Actual STAN experience

·        Dr. Larry Devoe:  Applicability/Usability of STAN in U.S.

10:10-10:25                        Break

10:25-11:25                        Presentation by FDA

·        Kathryn S. Daws-Kopp, lead reviewer

·        Julia A. Corrado, M.D., clinical reviewer

11:25-12:00                        Panel discussion

12:00-1:00                        Lunch

1:00-2:45                        Panel discussion

2:45-3:00                        Break

3:00-3:30                        Open public hearing

3:30-5:00                        Panel deliberations and vote

5:00                        Adjourn

*all times are approximate