BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S433 · Decision Oct 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR,
    PMA Number
    P980016
    Supplement Number
    S433
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 15, 2013
    Date Received
    August 12, 2013
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)