PMA P080020S032
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S032
- Product code
- MOZ
- Decision date
- 2019-03-13
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Sharing of the current facility and equipment used to manufacture Gel-One for the purpose of manufacturing another product in development.
Current openFDA PMA Record#
- Device
- Gel-One
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S032
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2019-03-13
- Decision code
- OK30
- Date received
- 2019-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sharing of the current facility and equipment used to manufacture Gel-One for the purpose of manufacturing another product in development.