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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.
 
DeviceTRILURON®
Generic NameAcid, hyaluronic, intraarticular
ApplicantFidia Farmaceutici S.P.A.
Via Ponte Della Fabbrica 3/A
Abano Terme 35031
PMA NumberP180040
Supplement NumberS002
Date Received07/11/2022
Decision Date08/08/2022
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 from manual to automated syringe quality inspection.
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