BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030054 · Supplement: S034 · Decision Feb 2, 2007
    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
    EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS
    PMA Number
    P030054
    Supplement Number
    S034
    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 2, 2007
    Date Received
    July 19, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE AF SUPPRESSION PACING FEATURE. THE SYSTEMS LISTED ABOVE ARE INDICATED AS FOLLOWS:THE SYSTEM IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION. IN PATIENTS INDICATED FOR AN ICD, THE SYSTEM IS ALSO INTENDED: 1) TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION; 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.

    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)