BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P200015 · Supplement: S011 · Decision Dec 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
    PMA Number
    P200015
    Supplement Number
    S011
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 16, 2021
    Date Received
    June 21, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    21M-1325

    Advisory Committee Statement

    Approval for the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent. The device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.

    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