BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P060039 · Decision Jun 13, 2008
    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
    ATTAIN STARFIX MODEL 4195 LEAD
    PMA Number
    P060039
    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
    June 13, 2008
    Date Received
    December 27, 2006
    Expedited Review
    N
    Docket Number
    08M-0478

    Advisory Committee Statement

    APPROVAL FOR THE ATTAIN STARFIX MODEL 4195 LEAD. THE ATTAIN STARFIX MODEL 4195 STEROID ELUTING, TRANSVENOUS LEAD WITH DEPLOYABLE LOBE FIXATION IS INTENDED FOR CHRONIC PACING AND SENSING OF THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE CARDIAC DEFIBRILLATOR.

    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