BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P220012 · Decision Oct 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    Aurora EV-ICD System
    PMA Number
    P220012
    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 20, 2023
    Date Received
    August 12, 2022
    Expedited Review
    N
    Docket Number
    23M-4553

    Advisory Committee Statement

    the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. Medical conditions that may indicate a patient for an EV-ICD for primary or secondary prevention of sudden cardiac death due to life-threatening ventricular tachyarrhythmias include: • Previous ventricular tachyarrhythmias• Coronary disease with left ventricular dysfunction• Cardiomyopathy• Inherited primary arrhythmia syndromes• Congenital heart diseaseNote: For patient-specific recommendations regarding indications for primary and secondary prevention of sudden cardiac death, refer to current clinical guidelines from the European Society of Cardiology (ESC), American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS).The Epsila EV™ MRI SureScan™ Model EV2401 extravascular lead is indicated for use in the anterior mediastinum for pacing therapies, cardioversion, and defibrillation when an extravascular implantable cardioverter defibrillator is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias. The Epsila EV EAZ101 Sternal Tunneling Tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead.The Epsila EV EAZ201 Transverse Tunneling Tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead.

    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)