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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNVISC HYLAN G-F 20
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS011
Date Received02/20/2007
Decision Date06/09/2008
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
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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