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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
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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