BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Supplement: S002 · Decision Sep 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM
    PMA Number
    P000009
    Supplement Number
    S002
    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
    September 4, 2001
    Date Received
    August 10, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE EMBEDDED AND PROGRAMMER SOFTWARE FOR THE TACHOS DR. THE NEW VERSION NUMBER FOR THE SOFTWARE CARTRIDGE FOR TACHOS DR/PHYLAX AV/TMS 1000 APPLICATIONS IS I-HDR.0.U/4 (MODEL 338 373). THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

    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