BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010012 · Supplement: S017 · Decision Feb 6, 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 AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
    PMA Number
    P010012
    Supplement Number
    S017
    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
    February 6, 2004
    Date Received
    November 13, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING. THE DEVICES ARE INDICATED FOR: FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.

    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)