|
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 | S012 |
Date Received | 09/08/2022 |
Decision Date | 10/07/2022 |
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 the Adverse Reactions section of the Product Information and Patient Information labeling based on post-market adverse event and safety data collected up to March 2022. |