PMA P170007S008
- Device
- DUROLANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S008
- Product code
- MOZ
- Decision date
- 2020-10-21
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Changes to the Water for Injection (WFI) and compressed air systems used in manufacture of DUROLANE.
Current openFDA PMA Record#
- Device
- DUROLANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S008
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-10-21
- Decision code
- OK30
- Date received
- 2020-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the Water for Injection (WFI) and compressed air systems used in manufacture of DUROLANE.