- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S051
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2023-01-05
- Decision code
- OK30
- Date received
- 2022-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sharing of the existing Gel-One manufacturing equipment in Preparation Building-3 in the SKK-Takahagi Plant to manufacture Gel-One samples using h-HAD manufactured atSKK-Kurihama Plant.