BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030054 · Supplement: S010 · Decision Nov 18, 2005
    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 AND ATLAS+ HF CRT-D SYSTEMS
    PMA Number
    P030054
    Supplement Number
    S010
    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
    November 18, 2005
    Date Received
    June 6, 2005
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    05M-0492

    Advisory Committee Statement

    APPROVAL FOR THE MODIFICATION OF THE INDICATIONS FOR THE EPIC AND ATLAS+ HF CRT-D SYSTEMS, SPECIFICALLY THE MAINTENANCE OF 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. THE ST. JUDE MEDICAL THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. IN PATIENTS INDICATED FOR AN ICD, THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE 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)