BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P200049 · Supplement: S007 · Decision Oct 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    System, Appendage Closure, Left Atrial
    Trade Name
    Amplatzer™ Amulet™ Left Atrial Appendage Occluder
    PMA Number
    P200049
    Supplement Number
    S007
    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
    October 1, 2024
    Date Received
    July 22, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of Centerpiece Tijuana Mexico as an alternative Ethylene Oxide (EO) sterilization facility for the sterilization of the provided devices in scope approved under the PMA/HDE numbers P000039, P02004, P200049, P120021, P040040, H070005, P190023

    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