PMA P980044S053
- Device
- SUPARTZ FX and VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S053
- Product code
- MOZ
- Decision date
- 2020-07-17
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Automation of the existing bacterial endotoxin test process.
Current openFDA PMA Record#
- Device
- SUPARTZ FX and VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S053
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-07-17
- Decision code
- OK30
- Date received
- 2020-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of the existing bacterial endotoxin test process.