BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P130013 · Supplement: S052 · Decision May 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    System, Appendage Closure, Left Atrial
    Trade Name
    WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
    PMA Number
    P130013
    Supplement Number
    S052
    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
    May 11, 2023
    Date Received
    September 28, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to add an alternative imaging modality option, intracardiac echocardiography (ICE), to the Instructions for Use (IFU) for use during the implant procedure. Additionally, you proposed updating the IFU with new clinical data, updating the Indications for Use to align with current practice, as well as streamline the IFU, Pouch Label, Spine Label, Carton Label, Patient Guide and Patient Implant Card in accordance with current labeling procedures.

    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