BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P050023 · Supplement: S056 · Decision Jan 11, 2013
    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
    COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD
    PMA Number
    P050023
    Supplement Number
    S056
    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
    January 11, 2013
    Date Received
    October 12, 2012
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATING THE LABELING FOR THE COROX FAMILY OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) PACING LEAD TO REFLECT THE FINDINGS OF THE COROX OTW STEROID LV MONITORING (COSMO) POST-APPROVAL STUDY.

    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