PMA P080020S026
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S026
- Product code
- MOZ
- Decision date
- 2018-03-15
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for a change to the water classification scheme for controls of the quality of the water used to manufacture Gel-One.
Current openFDA PMA Record#
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S026
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2018-03-15
- Decision code
- APPR
- Date received
- 2017-06-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the water classification scheme for controls of the quality of the water used to manufacture Gel-One.