BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P120017 · Supplement: S003 · Decision Jan 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    MYOCARDIAL PACING LEAD
    PMA Number
    P120017
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 25, 2016
    Date Received
    December 28, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.

    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