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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 One
Generic Nameacid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
50 binney street
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS044
Date Received12/17/2018
Decision Date01/16/2019
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modified sterilization cycles and loads for the sterilization of equipment parts used in the manufacturing of Synvisc and Synvisc-One.