BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Mitral Valve, Percutaneously Delivered

    PMA: P240042 · Decision May 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Prosthesis, Mitral Valve, Percutaneously Delivered
    Trade Name
    Tendyne Transcatheter Mitral Valve System
    PMA Number
    P240042
    Device Class
    FDA Class 3
    Product Code
    NPU
    Generic Name
    Prosthesis, mitral valve, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 23, 2025
    Date Received
    November 27, 2024
    Expedited Review
    N
    Docket Number
    25M-1506

    Advisory Committee Statement

    Approval for the Tendyne Transcatheter Mitral Valve System. This device is indicated for the treatment of symptomatic severe mitral valve dysfunction (moderate-to-severe or severe mitral regurgitation [MR], severe mitral stenosis [MS], or moderate MR with moderate or greater MS) associated with severe mitral annular calcification (MAC) in patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPU Prosthesis, Mitral Valve, Percutaneously Delivered