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U.S. Department of Health and Human Services

Devices@FDA
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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
ApplicantSanofi Genzyme Corp.
450 Water St.
Cambridge, MA 02141
PMA NumberP940015
Supplement NumberS052
Date Received12/03/2024
Decision Date01/02/2025
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a precaution statement stating the device is only intended for use by healthcare professionals adequately trained to administer intra-articular injections and revisions to the Synvisc® and Synvisc-One® patient labeling to include the same advisory statement.
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