BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010015 · Supplement: S005 · Decision Feb 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE
    PMA Number
    P010015
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 25, 2003
    Date Received
    March 4, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE WHICH IS INDICATED AS FOLLOWS: THE INSYNC III MODEL 8042 DEVICE IS INDICATED FOR THE REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA 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 <=35%, AND A QRS >=130 MS. RATE ADAPTIVE PACING IS PROVIDED FOR THOSE PATIENTS DEVELOPING A BRADYCARDIA INDICATION WHO MIGHT BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASE IN ACTIVITY. DUAL CHAMBER AND ATRIAL TRACKING MODES ARE INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)