BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P130012 · Decision Apr 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD
    PMA Number
    P130012
    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
    April 30, 2015
    Date Received
    May 13, 2013
    Expedited Review
    N
    Docket Number
    15M-1557

    Advisory Committee Statement

    APPROVAL FOR THE MYOPORE SUTURELESS MYOCARDIAL PACING LEAD. THIS DEVICE IS INDICATED FOR WHEN VENTRICULAR EPICARDIAL ATTACHMENT IS REQUIRED, OR WHEN A TRANSVENOUS LEAD CANNOT PROVIDE EFFECTIVE PACING. THIS TYPE OF LEAD IS USEFUL IN SITUATIONS WHERE IT IS REQUIRED THAT THE POTENTIAL FOR LEAD DISLODGEMENT BE DIMINISHED OR PACING AND/OR SENSING WILL BE ESTABLISHED SUBSEQUENT TO OPEN HEART SURGERY.

    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