BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010031 · Supplement: S057 · Decision Apr 17, 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
    MEDTRONIC CONCERTO MODEL C154DWK ICD
    PMA Number
    P010031
    Supplement Number
    S057
    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
    April 17, 2007
    Date Received
    November 7, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC CONCERTO MODELS C154DWK AND C164AWK ICD SYSTEMS AND CONCERTO-VIRTUOSO V1.2 SOFTWARE APPLICATION MODEL SW002. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC CONCERTO MODELS C154DWK AND C164AWK ICD SYSTEMS AND IS INDICATED AS FOLLOW: THE CONCERTO IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE 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 AND HAVE A LEFT VENTRICULAR EJECTION FRACTION # 35% AND A PROLONGED QRS DURATION. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.

    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)