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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeGeneral and Plastic Surgery Devices Panel
Date and TimeThe meeting was held on the following dates:
Oct 14, 2003 8:00 AM - 10:00 PM
Oct 15, 2003 7:30 AM - 5:00 PM
LocationGaithersburg Marriott, Grand Ballroom
9751 Washingtonian Blvd.
Gaithersburg , MD
Contact InformationDavid 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.fda.gov/cdrh/panelmtg.html for up-to-date information on this meeting.
AgendaOn 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.
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 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.
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: Text
Brief Summary: Text
Briefing: Text
Roster: Text
Slides: Text
Transcript: 10/14/03Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).