BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010012 · Supplement: S037 · Decision Mar 13, 2008
    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
    CONTAK RENEWAL 3 AVT CRT-D SYSTEM
    PMA Number
    P010012
    Supplement Number
    S037
    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
    March 13, 2008
    Date Received
    November 10, 2004
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    08M-0243

    Advisory Committee Statement

    APPROVAL FOR THE CONTAK RENEWAL 3 AVT AND CONTAK RENEWAL 3 AVT HE SYSTEMS. THE SYSTEMS ARE INDICATED FOR THE FOLLOWING: CONTAK RENEWAL 3 AVT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS. CONTAK RENEWAL 3 AVT PROVIDES ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT FOR PATIENTS WITH A HISTORY OF OR WHO ARE AT RISK OF DEVELOPING ATRIAL ARRHYTHMIAS.

    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)