|
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 | S008 |
Date Received | 03/30/2009 |
Decision Date | 10/11/2011 |
Product Code |
MOZ |
Docket Number | 11M-0736 |
Notice Date | 10/20/2011 |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00379236
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EUFLEXXA (1% SODIUM HYALURONATE). THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVENON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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