Fw: FDA Meeting Details for disapproval or approval of Silicone gel implants

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----- Original Message ----- From: ilena rose

ilena@...

Sent: Friday, August 29, 2003 11:56 AM

Subject: FDA Meeting Details for disapproval or approval of Silicone gel implants

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=388

Name of Committee

General and Plastic Surgery Devices Panel

Date and Time The meeting will be held on the following dates: Oct 14, 2003 8:00 AM - 10:00 PM Oct 15, 2003 7:30 AM - 5:00 PM

Location Gaithersburg Marriott, Grand Ballroom 9751 Washingtonian Blvd. Gaithersburg , MD

Hotel Accommodations A block of sleeping rooms has been reserved at the Gaithersburg Marriott, 9751 Washingtonian Blvd., Gaithersburg, MD (phone: 301-590-0044) for arrival on October 13, 2003, and departure on October 15, 2003. Rooms not reserved by September 22, 2003 will be released back to the hotel. Please reference FDA's General and Plastic Surgery Devices Panel when making your reservation.

Contact Information Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12519. Please call the Information Line or access the Internet address of http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=388 for up-to-date information on this meeting.

Agenda On October 14 and 15, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for Silicone Gel-Filled Breast Prostheses. Background information, including the agenda and questions for the committee, will be available to the public on October 10, 2003, on the Internet at http://www.fda.gov/cdrh/panelmtg.html.

Procedure 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 September 30, 2003. Oral presentations from the public will be scheduled on October 14, 2003, between approximately 8 a.m. and 12 m., and on October 15, 2003, between approximately 7:30 a.m. and 11:30 a.m. Time allotted for each presentation is limited. Those desiring to make formal oral presentations should notify the contact person before September 30, 2003, and submit a brief statement of the general nature of the comments they wish to present, and the names and addresses of proposed participants. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

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