BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Mitral Valve, Percutaneously Delivered

    PMA: P140031 · Supplement: S162 · Decision May 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Prosthesis, Mitral Valve, Percutaneously Delivered
    Trade Name
    Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems
    PMA Number
    P140031
    Supplement Number
    S162
    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, 2024
    Date Received
    August 1, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    24M-2539

    Advisory Committee Statement

    The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems are indicated for use in patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >/=4% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

    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