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

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P200046 · Supplement: S021 · Decision Sep 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Harmony™ Transcatheter Pulmonary Valve
    PMA Number
    P200046
    Supplement Number
    S021
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    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
    NPV Pulmonary Valve Prosthesis Percutaneously Delivered