BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S021 · Decision Sep 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER
    PMA Number
    P950037
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 10, 2001
    Date Received
    July 27, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE EXTERNAL DUAL-CHAMBER PACEMAKER MODELS EDP 30. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EDP 30 AND IS INDICATED FOR: 1) TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; 2) PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; 3) PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS, AND 4) EMERGENCY PACING.

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode