BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S037 · Decision Oct 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA
    PMA Number
    P980016
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 6, 2003
    Date Received
    September 8, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE MARQUIS VR AND DR SYSTEMS TO PROVIDE INCREASED ENERGY OUTPUT (35J). THE DEVICES WILL BE USED WITH THE FOLLOWING APPLICATION SOFTWARE VERSIONS: MODEL 9978 VERSION 1.0 APPLICATION SOFTWARE FOR USE WITH THE MAXIMO DR, AND MODEL 9979 VERSION 1.0 APPLICATION SOFTWARE FOR USE WITH MAXIMO VR. THE APPLICATION SOFTWARE MAY BE INSTALLED ON EITHER 9790C OR 2090 PROGRAMMERS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAXIMO DR/VR ICD SYSTEM AND ARE INDICATED AS FOLLOWS: THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 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
    LWS Implantable Cardioverter Defibrillator (Non-Crt)