PMA P080020S054
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S054
- Product code
- MOZ
- Decision date
- 2025-06-18
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- to share the existing Gel-One manufacturing equipment in Preparation Building-3 in the SKK Takahagi Plant for the manufacture of another product, FHA-Gel-One
Current openFDA PMA Record#
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S054
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to share the existing Gel-One manufacturing equipment in Preparation Building-3 in the SKK Takahagi Plant for the manufacture of another product, FHA-Gel-One