BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P140017 · Supplement: S014 · Decision Apr 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Melody TPV System
    PMA Number
    P140017
    Supplement Number
    S014
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 18, 2019
    Date Received
    November 13, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an update to labeling based on the results of your Post-Approval Study.

    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