|
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 | S010 |
Date Received | 11/17/2009 |
Decision Date | 10/25/2010 |
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 ADDITION OF NEW EQUIPMENT USED IN THE MANUFACTURING PROCESS TO INCREASE FINISHED PRODUCT LOT CAPACITY 3 ¿ 4 FOLD. |