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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 NumberS006
Date Received09/04/2020
Decision Date10/08/2020
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  
Change to the bacterial endotoxins (BE) acceptance limit for the glass syringe associated with change in BE test method.
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