Sixty-Fourth Meeting of the

Obstetrics and Gynecology Devices Panel
Gaithersburg Holiday Inn, Gaithersburg, Maryland

Agenda, Monday, May 21, 2001*

 Mallinckrodt OxiFirst Fetal Oxygen Saturation Monitoring System, Model N‑400 (P990053/S1)

 1:00-1:30    Introductory remarks
                              Colin Pollard, Chief, Obstetrics & Gynecology Devices Branch

 1:30-2:00    Open public hearing
                               ACOG, George Macones, M.D., University of Pennsylvania

 2:00-2:30    Presentation by NIH
                               Cathy Spong, M.D., Chief, Pregnancy and Perinatology Branch, PPB CRMC                              NICHD NIH

 2:30-3:00    Presentation by Mallinckrodt
                            Simon Thomas - Former Director of Perinatal Marketing and Former Senior                             Director of Perinatal Research & Development, Nellcor Business Unit of Tyco                            Healthcare's Respiratory Division

                             Richard P. Porreco, MD - Principal Investigator, Dystocia Study,                             Presbyterian/St. Luke's Medical Center, Denver, CO

 3:00-3:45    Panel discussion

 3:45-4:00    Panel vote

  Novatrix Labor Assister Device: Discussion of Regulatory Process Issues

  4:00-4:05    Introductory remarks  
                               Colin Pollard, Chief, Obstetrics & Gynecology Devices Branch

  4:05-4:30     Presentation by CareStat  
                                Howard Golub, Ph.D., M.D., President

  4:30-5:00     Questions from panel  

  5:00              Adjourn

 

*all times are approximate