PMA P180040S004
- Device
- TRILURON® (sodium hyaluronate)
- Applicant
- Fidia Farmaceutici S.P.A.
- PMA number
- P180040
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2023-01-19
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Change to the manufacturing procedure, including methods for filtration and washes for the sodium hyaluronate bulk powder.
Current openFDA PMA Record#
- Device
- TRILURON® (sodium hyaluronate)
- Applicant
- Fidia Farmaceutici S.P.A.
- PMA number
- P180040
- Supplement
- S004
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2023-01-19
- Decision code
- OK30
- Date received
- 2022-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the manufacturing procedure, including methods for filtration and washes for the sodium hyaluronate bulk powder.