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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
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
50 Binney Street
Cambridge, MA 02142
PMA NumberP940015
Supplement NumberS013
Date Received09/25/2008
Decision Date04/10/2009
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RELOCATION OF MANUFACTURING PROCESSES WITHIN THE SAME FACILITY AND THE ADDITION OF AN ALTERNATE SYRINGE FILLING MACHINE.
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