|
Device | EUFLEXXA® (1% sodium hyaluronate) |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | FERRING PHARMACEUTICALS, INC. 100 INTERPACE PARKWAY PARSIPPANY, NJ 07054 |
PMA Number | P010029 |
Supplement Number | S036 |
Date Received | 08/30/2023 |
Decision Date | 02/02/2024 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for introduction of new silicone gaskets for ceramic membranes of the Ultrafiltration (UF3) formulation and filling unit used in the manufacturing of the Euflexxa (1% sodium hyaluronate) product. |