PMA Applicant: Genzyme Biosurgery
Address: Genzyme Corporation, 55 Cambridge Parkway, Cambridge, MA 02142Approval Date: February 26, 2009
Synvisc-One™ (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan polymers (derivatives of hyaluronan or sodium hyaluronate) produced from chicken combs. Synvisc-One is a single 6 mL injection treatment regimen. The total treatment volume is identical between the currently marketed Synvisc (3 injection regimen, approved under P040015) and the Synvisc-One product.
ynvisc-One is designed as a single intra-articular injection option to reduce pain associated with osteoarthritis of the knee for up to 26 weeks. Side effects may include pain in the knee at the injection site, stiffness, swelling or warmth in or around the knee, changes in the way that you walk (e.g., limping).
Visit : http://www.fda.gov/cdrh/mda/
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