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 | TriVisc® |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | ORTHOGENRX,INC 3805 OLD EASTON ROAD DOYLESTOWN, PA 18902-8400 |
PMA Number | P160057 |
Supplement Number | S002 |
Date Received | 05/02/2023 |
Decision Date | 06/22/2023 |
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 Moving the manufacturing and sterilization site of the glass syringes (i.e., barrels) from BD Columbus, USA to BD Cuautitlán, Mexico. |
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