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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive
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Name of CommitteeObstetrics and Gynecology Devices Panel
Date and TimeThe meeting was held on the following dates:
Apr 22, 2002 8:00 AM - 5:00 PM
LocationGaithersburg Marriott Washingtonian Center
Salons E, F, and G, 9751 Washingtonian Blvd.
Gaithersburg , MD
Contact InformationJoyce M. Whang, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180 or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12524. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will discuss, make recommendations, and vote on a premarket approval application for an intrapartum fetal monitor. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the April 22 meeting will be posted on April 19, 2002.
ProcedureInterested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by April 11, 2002. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9 a.m. and between approximately 3 p.m. and 3:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal presentations should notify the contact person before April 11, 2002, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

ConductFDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.
Related Documents
Agenda: Draft agenda for meeting on STAN® S21 Fetal Heart Monitor (P020001) Text
Briefing: Briefing information for the meeting on STAN® S21 Fetal Heart Monitor (P020001) Text
Questions: Draft questions for meeting on STAN® S21 Fetal Heart Monitor (P020001) Text
Roster: Draft roster for the meeting on STAN® S21 Fetal Heart Monitor (P020001) Text
Summary: Text
Summary: Summary MinutesText
Transcript: Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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