Medical Devices

Company announces U.S. FDA 510(k) filing for antibiotic eluting surgical mesh

Published in Drug Week, February 17th, 2006

TyRx Pharma, Inc. announced that it has recently filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for its novel antimicrobial surgical mesh product. TyRx expects to launch this new surgical mesh in Q1 2006.

This is the second combination medical product that TyRx expects to market this year. In December 2005, FDA granted 510(k) clearance for TyRx's new bioresorbable polymer coated surgical mesh product. Like its predecessor, the TyRx antimicrobial mesh is designed to facilitate insertion and improve patient comfort long-term.

The TyRx bioresorbable polymer antibiotic eluting surgical mesh is indicated for the repair of...

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Source: Drug Week (2006-02-17)

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