BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P140017 · Supplement: S005 · Decision Feb 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D
    PMA Number
    P140017
    Supplement Number
    S005
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 24, 2017
    Date Received
    September 1, 2016
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    17M-1227

    Advisory Committee Statement

    Approval for the Melody Transcatheter Pulmonary Valve, Ensemble Transcatheter Valve Delivery System, and Ensemble II Transcatheter Valve Delivery System for expanding the indications to include patients with a dysfunctional surgical bioprosthetic pulmonary valve. The device is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has >= moderate regurgitation and/or a mean RVOT gradient >= 35 mmHg.

    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