BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P050046 · Decision Apr 13, 2007
    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
    ACUITY STEERABLE LEAD SYSTEM
    PMA Number
    P050046
    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 13, 2007
    Date Received
    October 14, 2005
    Expedited Review
    N
    Docket Number
    07M-0154

    Advisory Committee Statement

    APPROVAL FOR THE ACUITY STEERABLE LEAD MODELS 4554, 4555, AND 4556. THE GUIDANT ACUITY STEERABLE IS-1 CORONARY VENOUS, STEROID-ELUTING, DUAL-ELECTRODE PACE/SENSE LEADS ARE TRANSVENOUS LEADS INTENDED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR. EXTENDED BIPOLAR PACING AND SENSING IS AVAILABLE USING ACUITY STEERABLE WITH AN RV PACE/SENSE/DEFIBRILLATION LEAD OR A BIPOLAR RV PACE/SENSE 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