|
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 | S025 |
Date Received | 06/20/2017 |
Decision Date | 12/28/2017 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for BTG (Ferring) to manufacture, package and release Euflexxa at both the BTG (Ferring) and Lifecore facilities. |