BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010012 · Supplement: S023 · Decision Mar 9, 2004
    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
    CONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844
    PMA Number
    P010012
    Supplement Number
    S023
    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
    March 9, 2004
    Date Received
    January 16, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FIRMWARE MODIFICATIONS OF THE FOLLOWING AICD SYSTEMS: VENTAK PRIZM AICD SYSTEM (MODELS 1850, 1851, 1855, 1856) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM HE AICD SYSTEM (MODELS 1852, 1853, 1857, 1858) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM 2 AICD SYSTEM (MODELS 1860, 1861) FIRMWARE VERSION 1.4 PATCH C, VITALITY DS/EL AICD SYSTEM (MODELS T125, T127, T135) FIRMWARE VERSION 1.0 PATCH B, CONTAK CD 2 (MODELS H115, H119) FIRMWARE VERSION 1.2 PATCH H, AND THE APPLICATION SOFTWARE MODEL 2844 VERSION 3.7.

    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)