BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P200049 · Supplement: S014 · Decision Dec 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Appendage Closure, Left Atrial
    Trade Name
    Amplatzer™ Amulet™ Left Atrial Appendage Occluder
    PMA Number
    P200049
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    NGV
    Generic Name
    System, appendage closure, left atrial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 2025
    Date Received
    September 30, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for minor dimensional changes to the hemostasis valve accessory device supplied with the Amulet LAAO as well as clarifications to your instructions for use including updates to the MRI labeling.

    Classifications

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

    Product Code Device Name
    NGV System, Appendage Closure, Left Atrial