BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010031 · Supplement: S026 · Decision Oct 20, 2005
    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
    MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEMS
    PMA Number
    P010031
    Supplement Number
    S026
    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
    October 20, 2005
    Date Received
    September 16, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.

    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)