BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P140017 · Decision Jan 27, 2015
    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 (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)
    PMA Number
    P140017
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 27, 2015
    Date Received
    August 21, 2014
    Expedited Review
    Y
    Docket Number
    15M-0266

    Advisory Committee Statement

    APPROVAL THE MELODY TRANSCATHETER PULMONARY VALVE (TPV) AND THE ENSEMBLE TRANSCATHETER VALVE DELIVERYSYSTEM. THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SURGERY IN THE MANAGEMENT OF PEDIATRIC AND ADULT PATIENTS WITH THE FOLLOWING CLINICAL CONDITIONS:1) EXISTENCE OF A FULL (CIRCUMFERENTIAL) RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT THAT WAS EQUAL TO OR GREATER THAN 16 MM IN DIAMETER WHEN ORIGINALLY IMPLANTED, AND 2) DYSFUNCTIONAL RVOT CONDUIT WITH A CLINICAL INDICATION FOR INTERVENTION, AND: A) REGURGITATION >= MODERATE REGURGITATION, AND/OR B) STENOSIS: MEAN RVOT GRADIENT >= 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