PMA P980044S062
- Device
- SUPARTZ FX, VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S062
- Product code
- MOZ
- Decision date
- 2024-07-25
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- to discontinue all the apparent viscosity testing conducted as part of the in-process testing during the SUPARTZ device family manufacturing
Current openFDA PMA Record#
- Device
- SUPARTZ FX, VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S062
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2024-07-25
- Decision code
- OK30
- Date received
- 2024-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to discontinue all the apparent viscosity testing conducted as part of the in-process testing during the SUPARTZ device family manufacturing