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 and Synvisc-One |
Generic Name | acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 binney street cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S043 |
Date Received | 12/13/2018 |
Decision Date | 01/10/2019 |
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 Change to the frequency of routine sampling and testing of the water for injection and purified water systems. |
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