PMA P940015S051
- Device
- Synvisc, Synvisc-One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S051
- Product code
- MOZ
- Decision date
- 2023-01-13
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Replacement of the water distribution system (piping) used to supply water in the manufacture of Synvisc and Synvisc-One.
Current openFDA PMA Record#
- Device
- Synvisc, Synvisc-One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S051
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2023-01-13
- Decision code
- OK30
- Date received
- 2022-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the water distribution system (piping) used to supply water in the manufacture of Synvisc and Synvisc-One.