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. |
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Device | SYNVISC HYLAN G-F 20 |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S011 |
Date Received | 02/20/2007 |
Decision Date | 06/09/2008 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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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