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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNVISC HYLAN G-F 20
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
50 Binney Street
Cambridge, MA 02142
PMA NumberP940015
Supplement NumberS011
Date Received02/20/2007
Decision Date06/09/2008
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REPLACEMENT OF THE DILUTION STATEMENT FROM THE ?PRECAUTION? SECTION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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