PMA P170007S015

Device: DUROLANE
Applicant: Bioventus, LLC
PMA number: P170007
Supplement: S015
Product code: MOZ
Decision date: 2025-12-23
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for the installation of a newer model of distribution pump and new piping connecting the pump, the Water for Injection (WFI) tank, and the heat exchanger utilized in DUROLANE manufacturing.

Current openFDA PMA Record#

Device: DUROLANE
Applicant: Bioventus, LLC
PMA number: P170007
Supplement: S015
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2025-12-23
Decision code: OK30
Date received: 2025-11-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the installation of a newer model of distribution pump and new piping connecting the pump, the Water for Injection (WFI) tank, and the heat exchanger utilized in DUROLANE manufacturing.