PMA P170007S013
- Device
- Durolane
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S013
- Product code
- MOZ
- Decision date
- 2022-03-03
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Addition of an alternative supplier for sodium hydroxide and hydrochloric acid solutions used in the manufacturing of DUROLANE.
Current openFDA PMA Record#
- Device
- Durolane
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S013
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2022-03-03
- Decision code
- OK30
- Date received
- 2022-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative supplier for sodium hydroxide and hydrochloric acid solutions used in the manufacturing of DUROLANE.