Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HYALGAN |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | FIDIA FARMACEUTICI SPA VIA PONTE DELLA FABBRICA 3/A ABANO TERME, PADUA (PD) 35031 |
PMA Number | P950027 |
Supplement Number | S011 |
Date Received | 02/20/2008 |
Decision Date | 05/23/2008 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE SECTION OF ADVERSE EVENTS WITH A QUALITATIVE DESCRIPTION OF THE TYPES AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN. |
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