PMA P980044
- Device
- SUPARTZ FX; VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S059
- Product code
- MOZ
- Decision date
- 2025-12-19
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- discontinuation of antigenicity testing for the main component HA and the SUPARTZ device family as a lot release / quality control test
Current openFDA PMA Record#
- Device
- SUPARTZ FX; VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S065
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2025-12-19
- Decision code
- OK30
- Date received
- 2025-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- discontinuation of antigenicity testing for the main component HA and the SUPARTZ device family as a lot release / quality control test