BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P130013 · Supplement: S035 · Decision Jul 21, 2020
    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 and WATCHMAN Left Atrial Appendage Closure Device
    PMA Number
    P130013
    Supplement Number
    S035
    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
    July 21, 2020
    Date Received
    January 2, 2020
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    20M-1715

    Advisory Committee Statement

    Approval for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System. The supplement requested approval for a modified version of the WATCHMAN Left Atrial Appendage Closure Device with Delivery System referred to as the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and to expand the indications to include anticoagulation therapy. These devices are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:1) Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;2) Are deemed by their physicians to be suitable for anticoagulation therapy; and3) Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.

    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