|
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 | S047 |
Date Received | 04/30/2021 |
Decision Date | 10/27/2021 |
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 the use of existing filling and parts washing machines to manufacture a biologic when not in use for the manufacture of Synvisc and Synvisc-One. |