PMA P940015S046
- Device
- Synvisc, Synvisc-One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S046
- Product code
- MOZ
- Decision date
- 2020-07-17
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Change of storage time and storage conditions for dry fibers used in manufacture of Synvisc and Synvisc-One.
Current openFDA PMA Record#
- Device
- Synvisc, Synvisc-One
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S046
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-07-17
- Decision code
- OK30
- Date received
- 2020-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of storage time and storage conditions for dry fibers used in manufacture of Synvisc and Synvisc-One.