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 HYLAN G-F 20 |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S010 |
Date Received | 08/15/2003 |
Decision Date | 09/12/2003 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE PATIENT PACKAGE INSERT FOR SYNVISC THAT ARE INTENDED TO STRENGTHEN THE INFORMATION FOR PATIENTS BY INCREASING THE TYPE SIZE, DECREASING THE READING LEVEL, MORE FULLY DESCRIBING THE U.S. CLINICAL TRIAL, DESCRIBING THE SIGNS OF AN ALLERGIC REACTION, AND BY MAKING OTHER REVISIONS TO THE INSERT. |
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