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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.
 
DeviceGelsyn-3
Generic NameAcid, hyaluronic, intraarticular
ApplicantIbsa Institut Biochimique SA
Via Al Ponte 13, Ch-6903
Lugano Ticino 6903
PMA NumberP110005
Supplement NumberS014
Date Received12/12/2023
Decision Date01/11/2024
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
Approval Order Statement  
Approval for revisions to symbols utilized in the product labeling including the Product Information document, the needle label, and the product carton box label.
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