BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010012 · Decision May 2, 2002
    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,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
    PMA Number
    P010012
    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
    May 2, 2002
    Date Received
    February 27, 2001
    Expedited Review
    Y
    Docket Number
    02M-0236

    Advisory Committee Statement

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

    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)