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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
Classification Nameacid, hyaluronic, intraarticular
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS008
Date Received01/15/2003
Decision Date07/09/2003
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the shelf life of synvisc to 36 months at 30 degrees c.
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