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 | Gelsyn-3 |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | IBSA INSTITUT BIOCHIMIQUE SA VIA AL PONTE 13, CH-6903 LUGANO TICINO 6903 |
PMA Number | P110005 |
Supplement Number | S014 |
Date Received | 12/12/2023 |
Decision Date | 01/11/2024 |
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 revisions to symbols utilized in the product labeling including the Product Information document, the needle label, and the product carton box label. |
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