PMA P080020S055
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S055
- Product code
- MOZ
- Decision date
- 2026-04-09
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval of site change for manufacturing of device component
Current openFDA PMA Record#
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S055
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2026-04-09
- Decision code
- OK30
- Date received
- 2026-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of site change for manufacturing of device component