PMA P170007S011
- Device
- DUROLANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S011
- Product code
- MOZ
- Decision date
- 2022-01-25
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Use of the supplier's new facility for manufacture of the syringe component.
Current openFDA PMA Record#
- Device
- DUROLANE
- Applicant
- Bioventus, LLC
- PMA number
- P170007
- Supplement
- S011
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2022-01-25
- Decision code
- OK30
- Date received
- 2022-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of the supplier's new facility for manufacture of the syringe component.