PMA P170007S001
- Device
- DUROLOANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S001
- Product code
- MOZ
- Decision date
- 2018-08-17
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Replacement of a raw material supplier for a part used in the manufacture of DUROLANE.
Current openFDA PMA Record#
- Device
- DUROLOANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S001
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2018-08-17
- Decision code
- OK30
- Date received
- 2018-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of a raw material supplier for a part used in the manufacture of DUROLANE.