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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, SYNVISC-ONE
Generic Nameacid, hyaluronic, intraarticular
Applicant
Sanofi GENZYME CORP.
50 binney street
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS033
Date Received07/09/2014
Decision Date08/21/2014
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE UPDATING OF THE PACKAGE INSERT AND PATIENT INFORMATION LEAFLET WITH RESPECT TO ADVERSE EVENT INFORMATION ON PSEUDOSEPSIS, ALLERGIC REACTIONS, AND HYPERSENSITIVITY.
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