PMA P170007S003
- Device
- Durolane, Hyaluronic Acid, Stabilized Single Injection
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S003
- Product code
- MOZ
- Decision date
- 2019-06-08
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Alternative source of the sodium chloride solution utilized in the manufacture of DUROLANE.
Current openFDA PMA Record#
- Device
- Durolane, Hyaluronic Acid, Stabilized Single Injection
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S003
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2019-06-08
- Decision code
- OK30
- Date received
- 2019-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative source of the sodium chloride solution utilized in the manufacture of DUROLANE.