BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P080006 · Decision Apr 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
    Trade Name
    MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
    PMA Number
    P080006
    Device Class
    FDA Class 3
    Product Code
    OJX
    Generic Name
    Drug eluting permanent left ventricular (lv) pacemaker electrode
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 7, 2009
    Date Received
    March 14, 2008
    Expedited Review
    N
    Docket Number
    09M-0182

    Advisory Committee Statement

    APPROVAL FOR THE ATTAIN ABILITY MODEL 4196 LEAD. THE ATTAIN ABILITY MODEL 4196 STEROID ELUTING, DUAL ELECTRODE, IS-1TRANSVENOUS LEAD IS INDICATED FOR CHRONIC PACING AND SENSING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM. EXTENDED BIPOLAR PACING IS AVAILABLE USING THIS LEAD IN COMBINATION WITH A COMPATIBLE CRT-D SYSTEM AND RV DEFIBRILLATION LEAD OR WITH A COMPATIBLE CRT-P SYSTEM AND RV PACING LEAD.

    Classifications

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

    Product Code Device Name
    OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode