|
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 | S030 |
Date Received | 04/02/2020 |
Decision Date | 04/16/2020 |
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 in manufacturing to shorten the time required for the concentration step during formulation by slightly increasing the pressure and reducing the concentration time in the UF (ultrafiltration) unit. |