Lifecore Files PMA Amendment for Intergel Adhesion Prevention Solution
From: Helen Dynda (email@example.com)
Tue Jun 20 13:47:11 2000
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LIFECORE FILES PMA AMENDMENT FOR
INTERGEL® ADHESION PREVENTION SOLUTION
CHASKA, MN. June 5, 2000 -- LIFECORE BIOMEDICAL, INC. (Nasdaq: LCBM) announced today that it filed an amendment to its pre-market approval application for INTERGEL® Adhesion Prevention Solution with the FDA's Center for Devices and Radiological Health on June 2. The purpose of the amendment is to respond to a General and Plastic Surgery Devices Advisory Panel Meeting held on January 12, 2000 where panel members voted not to approve the product.
INTERGEL® Solution has been under evaluation in pivotal human clinical trials since March 1996. The current premarket approval application was filed with the FDA in March 1999 and formally accepted for expedited review in May 1999. While the Company believes it has satisfactorily answered all questions raised at the January panel meeting, there can be no assurance that the Company's response will be adequate to obtain approval to market the product in the US.