BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P010031 · Supplement: S433 · Decision May 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    MAXIMO II CRT-D, CONCERTO, CONCERTO II CRT-D, CONSULTA, INSYNC II & IIIMARQUIS, MAXIMO, SENTRY, MARQUIS INSYNC II PROTEC
    PMA Number
    P010031
    Supplement Number
    S433
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 16, 2014
    Date Received
    March 18, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.

    Classifications

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

    Product Code Device Name
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)