PMA P980044S055
- Device
- SUPARTZ device family, SUPARTZ FX and VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S055
- Product code
- MOZ
- Decision date
- 2021-04-15
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Sharing the facility and equipment used to manufacture SUPARTZ FX and VISCO-3 for the purpose of manufacturing an investigational drug substance
Current openFDA PMA Record#
- Device
- SUPARTZ device family, SUPARTZ FX and VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S055
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2021-04-15
- Decision code
- OK30
- Date received
- 2021-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sharing the facility and equipment used to manufacture SUPARTZ FX and VISCO-3 for the purpose of manufacturing an investigational drug substance