PMA P940015S044
- Device
- Synvisc One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S044
- Product code
- MOZ
- Decision date
- 2019-01-16
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Modified sterilization cycles and loads for the sterilization of equipment parts used in the manufacturing of Synvisc and Synvisc-One.
Current openFDA PMA Record#
- Device
- Synvisc One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S044
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2019-01-16
- Decision code
- OK30
- Date received
- 2018-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modified sterilization cycles and loads for the sterilization of equipment parts used in the manufacturing of Synvisc and Synvisc-One.