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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
Applicant
Sanofi GENZYME CORP.
50 binney street
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS043
Date Received12/13/2018
Decision Date01/10/2019
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the frequency of routine sampling and testing of the water for injection and purified water systems.
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