|
Device | TRILURON® (sodium hyaluronate) |
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 | S004 |
Date Received | 12/23/2022 |
Decision Date | 01/19/2023 |
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 manufacturing procedure, including methods for filtration and washes for the sodium hyaluronate bulk powder. |