PMA P980044S043
- Device
- Supartz FX and Visco-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S043
- Product code
- MOZ
- Decision date
- 2018-03-14
- Classification
- Acid, Hyaluronic, Intraarticular
- 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 the manufacturing of an investigational drug product.
Current openFDA PMA Record#
- Device
- Supartz FX and Visco-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S043
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2018-03-14
- Decision code
- OK30
- Date received
- 2018-02-13
- 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 the manufacturing of an investigational drug product.