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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.
 
DeviceSYNOJOYNT™
Generic NameAcid, hyaluronic, intraarticular
ApplicantMesoblast
Level 38
55 Collins St.
Melbourne 3000
PMA NumberP170016
Supplement NumberS001
Date Received10/31/2025
Decision Date12/23/2025
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the replacement and relocation of the blistering and labeling equipment and minor change to process and size of label.
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