PMA P080020S037
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S037
- Product code
- MOZ
- Decision date
- 2020-03-31
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Modification of equipment required for manufacturing the new Finger Grip of the Gel-One container closure system.
Current openFDA PMA Record#
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S037
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-03-31
- Decision code
- OK30
- Date received
- 2020-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of equipment required for manufacturing the new Finger Grip of the Gel-One container closure system.