FDA GRANTS LIFECORE REQUEST FOR DISPUTE RESOLUTION

From: Helen Dynda (olddad66@runestone.net)
Sat Apr 14 18:00:43 2001


FDA GRANTS LIFECORE REQUEST FOR DISPUTE RESOLUTION

http://www.lifecore.com/press_release_048.htm

PANEL REVIEW OF ADHESION PREVENTION SOLUTION PRODUCT

CHASKA, MN. February 7, 2001 -- LIFECORE BIOMEDICAL, INC. (Nasdaq: LCBM) announced today that the Food and Drug Administration has granted the Company's request for review by the Medical Devices Dispute Resolution Panel (MDDRP) of the scientific disputes that have arisen in connection with Lifecore's pending PMA application for its ferric hyaluronan product, GYNECARE INTERGEL* Adhesion Prevention Solution.

Les Weinstein, Ombudsman in FDA's Center for Devices and Radiological Health (CDRH) and MDDRP Executive Secretary indicated that he would convene the Panel as expeditiously as possible. The review will be the first such MDDRP granted under the auspices of the FDA Modernization Act of 1997.


Enter keywords:
Returns per screen: Require all keywords: