BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P830061 · Supplement: S035 · Decision May 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON...
    PMA Number
    P830061
    Supplement Number
    S035
    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
    May 9, 2003
    Date Received
    December 24, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.

    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