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Article: Biomatrix Files 510(k) Submission with FDA for Surgical Adhesion Prevention Product.
- Article from:
- PR Newswire
- Article date:
- December 16, 1999
CopyrightCOPYRIGHT 1999 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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RIDGEFIELD, N.J., Dec. 15 /PRNewswire/ -- Biomatrix, Inc. (NYSE: BXM) today announced that the Company has submitted a Section 510(k) pre-market notification to the U.S. Food & Drug Administration (FDA) for Hylasine(R). Hylasine is the company's viscoelastic gel device that is injected into anatomical compartments of the sinus during and following sinus surgery to coat surgically altered tissue, to still intra-operative and post-operative bleeding, to reduce post-surgical scarring and adhesions, to minimize patient discomfort and to diminish the patient post-operative rehabilitation period. These intra-operative and post-operative complications appear in many of the ...