BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P140017 · Supplement: S035 · Decision Jun 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th
    PMA Number
    P140017
    Supplement Number
    S035
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 9, 2026
    Date Received
    March 26, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for secondary packaging changes, including a new shipping temperature indicator, and minor labeling changes.

    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