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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeMedical Devices Dispute Resolution Panel
Date and TimeThe meeting was held on the following dates:
Sep 6, 2001 8:00 AM - 6:00 PM
LocationGaithersburg Marriott, Salons E, F and G,
9751 Washingtonian Blvd.
Gaithersburg , MD
Contact InformationLes Weinstein, Center for Devices and Radiological Health (HFZ-5), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-6220, ext. 119, FAX 301-827-2565, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 10232. Please call the Information Line for up-to-date information on this meeting. (E-mail contact LSW@cdrh.fda.gov)
AgendaThe committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Lifecore Biomedical, Inc. related to the approvability of a premarket approval application for Intergel, an adhesion prevention solution for use in gynecologic pelvic surgery. Background information and questions for the committee will be available to the public on September 5, 2001, 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 4, 2001. Oral presentations from the public will be scheduled between approximately 8 a.m. and 8:30 a.m. on September 6, 2001. Near the end of the committee deliberations, a 30-minute open public session will be conducted for interested persons to address issues specific to the dispute before the committee. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 4, 2001, 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.
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: Text
Minutes: Text
Summary: Text
Transcript: Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).