Sixty

Sixty-Fourth Meeting of the
Obstetrics and Gynecology Devices Panel

Monday & Tuesday, May 21 & 22, 2001
Gaithersburg Holiday Inn, Gaithersburg, Maryland

Briefing Information

Mallinckrodt OxiFirstÒ Fetal Oxygen Saturation Monitoring System, Model N-400 (P990053/S1)

Discussion questions & background materials pdf html
FDA Approval Package for the PMA html
Garite, T.J., Dildy, G.A., McNamara, H., Nageotte, M.P., Boehm, F.H., Dellinger, E.H., Knuppel, R.A., Porreco, R.P., Miller, H.S., Sunderji, S., Varner, M.W., Swedlow, D.B., "A multicenter controlled trial of fetal pulse oximetery in the intrapartum management of nonreassuring fetal heart rate patterns," Am J Ob Gyn 183:1049-1058, 2000.*
Summary of Post-Approval Clinical Studies Plans pdf

Room Air and Gas Emboli Associated with Operative Hysteroscopy

Discussion questions & background materials pdf
VersaPoint bipolar electrodes:

Summary of "Consensus Statement" and appraisal of case reports   pdf    html

Letters for withdrawal & reintroduction   pdf

Ethicon Laboratory work: gas production rates   pdf

Uterine Fibroid Embolization (UFE)

Discussion questions & background materials pdf   html

Fibroid registry protocol   pdf

Fibroid registry case report form   pdf

*Copyrighted material may be viewed at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, between the hours of 9:00 am to 4:00 pm, Monday through Friday except Federal holidays.