BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P030035 · Supplement: S003 · Decision Apr 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS
    PMA Number
    P030035
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 29, 2005
    Date Received
    September 30, 2004
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    05M-0289

    Advisory Committee Statement

    APPROVAL FOR THE FRONTIER CARDIAC RESYNCHRONIZATION THERAPY SYSTEM. THESE DEVICES ARE INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. 2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)