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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 NumberS009
Date Received03/31/2021
Decision Date09/02/2021
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-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 addition of an alternative supplier of a raw hyaluronic acid salt material component.
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