|
Device | Synvisc and Synvisc-One |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S050 |
Date Received | 09/30/2022 |
Decision Date | 11/04/2022 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a warning statement regarding skin necrosis and the Synvisc® and Synvisc-One® patient labeling to include an advisory for the patient to inform his/her doctor in the event of development of a skin disorder after treatment. |