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. |
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Device | TRILURON® |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A Abano Terme 35031 |
PMA Number | P180040 |
Supplement Number | S003 |
Date Received | 09/08/2022 |
Decision Date | 10/04/2022 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the storage condition for the sodium hyaluronate bulk powder. |
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