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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.
 
DeviceSYNVISC
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
GENZYME CORP.
55 cambridge parkway
4th floor
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS008
Date Received01/15/2003
Decision Date07/09/2003
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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