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Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

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 material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).

Closed Committee Deliberations:
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 .

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

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-0450, ext . 113, at least 7 days in advance of the meeting.

Contact Person:
Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524.