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U.S. Department of Health and Human Services

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Medical Devices Dispute Resolution Panel Meeting Summary for September 6, 2001

On September 6, 2001, the Medical Devices Dispute Resolution Panel met to resolve a scientific dispute between FDA and Lifecore Biomedical, Inc. regarding its PMA 990015, as amended, for Intergel Adhesion Prevention Solution. This product is for use as an intraperitoneal instillate for reduction of adhesion formation following gynecologic pelvic surgery. FDA had previously issued a not-approvable letter which Lifecore appealed to this Panel. The Panel voted 4 to 0 in favor of a recommendation to approve the PMA.

Contact: Les Weinstein, Executive Secretary; 301-443-6220 x119

Transcripts may be purchased from: (written request only)
Neal R. Gross and Company
1323 Rhode Island Avenue., N.W.
Washington, D.C. 20005
202-234-4433
or
Food and Drug Administration
Division of Freedom of Information (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice) 301-443-1726 (fax)

Executive Summary may be purchased from: (written request only)
Food and Drug Administration
Division of Freedom of Information (FOI)
5600 Fishers Lane
Rockville, MD 20852
301-827-6500(voice) 301-443-1726 (fax)

CDRH Advisory Committee Database