PMA P080020S035
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S035
- Product code
- MOZ
- Decision date
- 2019-10-30
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for a change to the design of the Finger Grip of the Gel-One container closure system.
Current openFDA PMA Record#
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S035
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2019-10-30
- Decision code
- APPR
- Date received
- 2019-08-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the design of the Finger Grip of the Gel-One container closure system.