PMA P940015S049
- Device
- Synvisc, Synvisc-One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S049
- Product code
- MOZ
- Decision date
- 2021-09-03
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Use of sterile connectors for manufacture of Synvisc and Synvisc-One as an alternative to aseptic connections.
Current openFDA PMA Record#
- Device
- Synvisc, Synvisc-One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S049
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2021-09-03
- Decision code
- OK30
- Date received
- 2021-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of sterile connectors for manufacture of Synvisc and Synvisc-One as an alternative to aseptic connections.