BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P130013 · Supplement: S075 · Decision May 5, 2025
    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; WATCHMAN FLX Pro Left Atrial Appendage Closure D
    PMA Number
    P130013
    Supplement Number
    S075
    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 5, 2025
    Date Received
    February 4, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding an alternative braiding method, including a component-level manufacturing process, design specification changes, and new visual standards used in inspection processes, for the manufacture of the insourced Delivery Sheath component of the WATCHMAN FLX ™ and WATCHMAN FLX Pro ™ Left Atrial Appendage (LAA) Closure Devices with Delivery Systems.

    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