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Home » TYRX PHARMA, INC., ANNOUNCES FDA CLEARANCE OF PIVIT AB, A NOVEL ANTIMICROBIAL-COATED SURGICAL MESH
TYRX PHARMA, INC., ANNOUNCES FDA CLEARANCE OF PIVIT AB, A NOVEL ANTIMICROBIAL-COATED SURGICAL MESH
July 31, 2006
TyRx Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for PIVIT AB, a new surgical mesh product coated with a proprietary bioresorbable polymer containing the antimicrobial agents rifampin and minocycline. TyRx expects to launch this new surgical mesh during the 3rd quarter of 2006. PIVIT AB is indicated for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The antimicrobial coating is designed to help provide protection from microbial colonization of the device during surgical implantation.
KEYWORDS FDAnews Device Daily Bulletin
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