BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    PMA: P010031 · Supplement: S061 · Decision Jan 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
    Trade Name
    INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS
    PMA Number
    P010031
    Supplement Number
    S061
    Device Class
    FDA Class 3
    Product Code
    NIK
    Generic Name
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 30, 2007
    Date Received
    December 20, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE. THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2.

    Classifications

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

    Product Code Device Name
    NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)