BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P080006 · Supplement: S004 · Decision Mar 31, 2011
    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 STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD
    PMA Number
    P080006
    Supplement Number
    S004
    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
    March 31, 2011
    Date Received
    October 19, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD. THE MODEL 4396 LEAD IS A 4 FRENCH, TRANSVENOUS, STEROID ELUTING, DUAL ELECTRODE, POLYURETHANE INSULATED, SINGLE COIL, STRAIGHT TIP, TINE FIXATION LEAD INTENDED FOR USE IN LEFT HEART CORONARY VEINS.

    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