BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P130013 · Supplement: S043 · Decision Sep 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    System, Appendage Closure, Left Atrial
    Trade Name
    WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems
    PMA Number
    P130013
    Supplement Number
    S043
    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
    September 2, 2022
    Date Received
    March 31, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of dual antiplatelet therapy (DAPT) as an alterative post-implant antithrombotic medication regimen.

    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