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| Name of Committee | Obstetrics and Gynecology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Jul 22, 2002 8:30 AM - 5:00 PM
Jul 23, 2002 8:00 AM - 11:00 AM
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| Location | DoubleTree Hotel
1750 Rockville Pike, Plaza I and II
Rockville
, MD |
| Contact Information | Joyce 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. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line or access this Internet page for up-to-date information on this meeting. (E-mail contact jmw@cdrh.fda.gov) |
| Agenda | On July 22, 2002, the committee will hear a presentation on post-market surveillance of vacuum assisted delivery devices. The committee will also discuss, make recommendations, and vote on a premarket approval application for a permanent contraceptive device. 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 July 22 session will be posted on July 19, 2002. |
| Procedure | On July 22, 2002, from 8:30 a.m. to 5 p.m., the meeting is open to the public. Interested 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 July 11, 2002. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m., and between approximately 3:30 p.m. and 4 p.m. on July 22, 2002. Time allotted for each presentation may be limited. Those desiring to make formal presentations should notify the contact person before July 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. |
| Closed Committee Information | On July 23, 2002, from 8 a.m. to 11 a.m., the meeting will be closed to the public to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) regarding pending and future device issues. In addition, the committee will discuss and review trade secret and/or confidential commercial information presented by a sponsor. |
| Conduct | FDA 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 | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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