PMA P080020S045
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S045
- Product code
- MOZ
- Decision date
- 2021-10-04
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Addition of a new supplier for a raw material used in the manufacture of Gel-One.
Current openFDA PMA Record#
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S045
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2021-10-04
- Decision code
- OK30
- Date received
- 2021-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new supplier for a raw material used in the manufacture of Gel-One.