|
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 | S009 |
Date Received | 03/31/2021 |
Decision Date | 09/02/2021 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of an alternative supplier of a raw hyaluronic acid salt material component. |