PMA P170007S007
- Device
- DUROLANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S007
- Product code
- MOZ
- Decision date
- 2020-11-29
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for the addition of a second supplier of the sodium hyaluronate raw material used in the manufacture of DUROLANE.
Current openFDA PMA Record#
- Device
- DUROLANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S007
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-11-29
- Decision code
- APPR
- Date received
- 2020-09-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a second supplier of the sodium hyaluronate raw material used in the manufacture of DUROLANE.