- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S031
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2018-12-06
- Decision code
- OK30
- Date received
- 2018-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Installation of two new sterility test isolators and a new laminar flow hood, as well as associated changes involving relocation of various sterility and bioburden testing activities and equipment.