BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P050023 · Decision Aug 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
    PMA Number
    P050023
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 10, 2006
    Date Received
    July 11, 2005
    Expedited Review
    N
    Docket Number
    06M-0367

    Advisory Committee Statement

    APPROVAL FOR THE TUPOS LV/ATX CRT-D, KRONOS LV-T CRT-D, 505.U PROGRAMMER SOFTWARE FOR THE ICS 3000, A-K00.7.U PROGRAMMER SOFTWARE FOR THE EPR/TMS 1000PLUS AND COROX OTW STEROID LEAD. THE TUPOS LV/ATX AND KRONOS LV-T CRT-DS ARE INDICATED FOR USE IN PATIENTS WITH ALL OF THE FOLLOWING CONDITIONS: 1) INDICATED FOR ICD THERAPY; 2) RECEIVING OPTIMIZED AND STABLE CONGESTIVE HEART FAILURE (CHF) DRUG THERAPY; 3) SYMPTOMATIC CHF (NYHA CLASS III/IV AND LVEF <=35%); AND 4) INTRAVENTRICULAR CONDUCTION DELAY (QRS DURATION >=130 MS). THE TUPOS LV/ATX IS ALSO INDICATED FOR PATIENTS WHO, IN ADDITION TO AN INDICATION FOR A CRT-D DEVICE, HAVE ATRIAL TACHYARRHYTHMIAS OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE COROX OTW STEROID LEADS ARE INTENDED FOR IMPLANTATION VIA THE CORONARY VEINS TO PROVIDE LONG TERM CARDIAC PACING WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.

    Classifications

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

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber