PMA P980044S051
- Device
- SUPARTZ FX; VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S051
- Product code
- MOZ
- Decision date
- 2019-01-18
- 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 product.
Current openFDA PMA Record#
- Device
- SUPARTZ FX; VISCO-3
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S051
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2019-01-18
- Decision code
- OK30
- Date received
- 2018-12-20
- 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 product.