BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Appendage Closure, Left Atrial

    PMA: P130013 · Supplement: S025 · Decision Mar 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    System, Appendage Closure, Left Atrial
    Trade Name
    Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System
    PMA Number
    P130013
    Supplement Number
    S025
    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
    March 1, 2019
    Date Received
    December 7, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for approval for a manufacturing site, Synergy Health Ireland Ltd., (a STERIS Company), located at IDA Business and Technology Park, Srah, Tullamore, County Offaly, Ireland, as a new ethylene oxide (EO) sterilization site for the WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System.

    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