BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P170006 · Supplement: S027 · Decision Sep 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    Avalus™ Bioprosthesis
    PMA Number
    P170006
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 25, 2023
    Date Received
    September 12, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New sterilization cycle for moist heat sterilization of the primary packaging for the Evolut R, PRO, PRO+, FX Transcatheter Aortic Valves (TAV), the Harmony and Melody Transcatheter Pulmonary Valves (TPV), and the Avalus Bioprosthesis manufactured in Tijuana, Mexico. Additionally, a new sterilization configuration for the primary packaging sterilization is also being introduced for the Evolut TAV jars and Harmony TPV jars.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue