PMA P980044S063
- Device
- SUPARTZ FX; VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S063
- Product code
- MOZ
- Decision date
- 2025-07-22
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- change to install an automated visual inspection (AVI) system to one line of the in-process inspection line used for the SUPARTZ product family
Current openFDA PMA Record#
- Device
- SUPARTZ FX; VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S063
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2025-07-22
- Decision code
- OK30
- Date received
- 2025-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change to install an automated visual inspection (AVI) system to one line of the in-process inspection line used for the SUPARTZ product family