FDA Grants Lifecore Request for Dispute Resolution Panel Review of Adhesion Prevention Solution Product.Business Editors & Health Writers CHASKA, Minn.--(BUSINESS WIRE)--Feb. 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 PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy application for its ferric ferric (fĕr`ĭk), iron in the +3 valence state. See ferrous. hyaluronan product, GYNECARE INTERGEL(a) Adhesion Prevention Solution. Les Weinstein, Ombudsman in FDA's Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. (CDRH CDRH Center for Devices and Radiological Health (US FDA) ) 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Modernization Act of 1997. Certain statements in this release are forward-looking statements as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Statements implying timing or outcome of the FDA review process and the MDDRP are subject to change. Because of numerous risks and uncertainties in the complex regulatory aspects of Lifecore's business activity, actual results may differ materially from those implied. Investors are strongly cautioned to review more detailed discussions of those risks presented in the Company's Forms 10-Q and 10-K. Lifecore Biomedical manufactures biomaterials and surgical devices for use in various surgical markets and provides specialized contract aseptic manufacturing services. Additional general corporate information about Lifecore is available on the Internet at http://www.lifecore.com (a) Trademark of ETHICON, INC. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion