PMA P170007S004
- Device
- Durolane
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2019-09-19
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Extension of the designated shelf life of the HA raw material used in the manufacture of Durolane.
Current openFDA PMA Record#
- Device
- Durolane
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S004
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2019-09-19
- Decision code
- OK30
- Date received
- 2019-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extension of the designated shelf life of the HA raw material used in the manufacture of Durolane.