PMA P080020S039
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S039
- Product code
- MOZ
- Decision date
- 2020-11-12
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Replacement of the filter integrity test system.
Current openFDA PMA Record#
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S039
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-11-12
- Decision code
- OK30
- Date received
- 2020-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the filter integrity test system.