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 | SYNVISC, SYNVISC-ONE |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S033 |
Date Received | 07/09/2014 |
Decision Date | 08/21/2014 |
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 THE UPDATING OF THE PACKAGE INSERT AND PATIENT INFORMATION LEAFLET WITH RESPECT TO ADVERSE EVENT INFORMATION ON PSEUDOSEPSIS, ALLERGIC REACTIONS, AND HYPERSENSITIVITY. |
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