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 (HYLAN G-F 20) |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S014 |
Date Received | 02/17/2009 |
Decision Date | 03/11/2009 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REMOVAL OF THE CYTOTOXICITY TEST (USP<87> BIOLOGICAL REACTIVITY TEST, IN VITRO) FROM THE HYLAN B-10 GEL IN-PROCESS SPECIFICATION FOR THE DEVICE. |
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