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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:
Apr 11, 05 8:00 AM - 5:30 PM
Apr 12, 05 8:00 AM - 6:00 PM
Apr 13, 05 8:00 AM - 6:00 PM
LocationHilton Washington DC North/Gaithersburg, Grand Ballroom
620 Perry Parkway
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 3014512519. 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. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line or access this Internet page for up-to-date information on this meeting.
AgendaOn April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Background information, including the agenda and questions for the committee, will be available to the public on April 8, 2005, 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 March 28, 2005. Oral presentations from the public will be scheduled on April 11, 2005, between approximately 8 a.m. and 5:30 p.m., and on April 12 and 13, 2005, between approximately 2:45 p.m. and 3:45 p.m. Time allotted for each presentation is limited. Those desiring to make formal oral presentations should notify the contact person before March 28, 2005, 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
Briefing: Text
Roster: Text
Slides: FDA SlidesText
Summary: Text
Transcript: April 11, 2005, Morning in HTMLText
Transcript: April 11, 2005, Morning in WORDWord
Transcript: April 11, 2005, Evening in HTMLText
Transcript: April 11, 2005, Evening in WORDWord
Transcript: April 12, 2005 in HTMLText
Transcript: April 13, 2005 in HTMLText
Transcript:April 13, 2005 in WORDWord
Transcript: April 12, 2005 in WORDWord
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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