PMA P940015S047

Device: SYNVISC and SYNVISC ONE
Applicant: Sanofi Genzyme Corp.
Product code: MOZ
Decision date: 2021-10-27
Generic name: Acid, hyaluronic, intraarticular
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.

Current openFDA PMA Record#

Device: SYNVISC and SYNVISC ONE
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S047
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2021-10-27
Decision code: APPR
Date received: 2021-04-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.