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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 and Synvisc-One
Generic Nameacid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
50 binney street
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS041
Date Received05/24/2018
Decision Date11/02/2018
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 an additional test point for sterility and endotoxin during manufacturing of the SynVisc and SynVisc One devices.
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