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| Name of Committee | Obstetrics and Gynecology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Mar 27, 06 10:00 AM - 5:45 PM
Mar 28, 06 8:00 AM - 3:00 PM
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| Location | Hilton Washington DC/North Gaithersburg, Salons A, B, and C
620 Perry Parkway
Gaithersburg
, MD |
| Contact Information | Michael Bailey, 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 3014512524. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | On March 27, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application for a post-surgical adhesion prevention device for use in patients undergoing gynecological laparoscopic surgical procedures. On March 28, 2006, the committee will have a general topic discussion of clinical trial design issues for new devices intended to treat symptomatic uterine fibroids. Background information, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. |
| Procedure | On March 27, 2006, from 10 a.m. to 5:45 p.m., and on March 28, 2006, from 9 a.m. to 3 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 March 20, 2006. Oral presentations from the public will be scheduled on March 27, 2006, between approximately 10:10 a.m. and 10:40 a.m. and between approximately 4:15 p.m. and 4:45 p.m., and on March 28, 2006, between approximately 10:15 a.m. and 11:15 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 21, 2006, 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. |
| Closed Committee Information | On March 28, 2006, from 8 a.m. to 9 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) regarding pending and future device issues. |
| | Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| 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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