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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:
Jul 8, 2002 1:00 PM - 5:00 PM
Jul 9, 2002 8:00 AM - 5:00 PM
LocationGaithersburg Holiday Inn, Ballroom
Two Montgomery Village Ave.
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 July 8, 2002, the committee will discuss and make recommendations on the classification of a preamendment device, the silicone elastomer for scar management. The committee will also discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. On July 9, 2002, the FDA and two manufacturers of approved saline inflatable breast implant devices will present postmarket information to the committee for their consideration. Background information for each day’s topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 8 session will be posted on July 5, 2002; material for the July 9 session will be posted on July 8, 2002.
ProcedureOn July 8, 2002, from 1:30 p.m. to 5 p.m., and on July 9, 2002, from 8 a.m. to 5 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 June 24, 2002. Oral presentations from the public will be scheduled between approximately 1:45 p.m. and 2:15 p.m., and between approximately 4 p.m. and 4:30 p.m. on July 8, 2002; and between approximately 8:30 a.m. and 10:30 a.m. on July 9, 2002. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before June 24, 2002, 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.

Closed Committee InformationOn July 8, 2002, from 1 p.m. to 1:30 p.m., the meeting will be closed to permit FDA to present to the committee trade secret and/or confidential commercial information (5 U.S.C. 552b(c) (4)) relating to pending issues and applications.
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
Briefing: For 7/9/02Text
Briefing: For 7/8/02Text
Summary: Text
Summary:For 7/9/02Rich Text Format
Transcript:For 7/8/02Rich Text Format
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).