BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P850089 · Supplement: S046 · Decision Jun 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    CAPSURE SP NOVUS LEAD MODEL 5594
    PMA Number
    P850089
    Supplement Number
    S046
    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
    June 14, 2001
    Date Received
    May 21, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CAPSURE SP NOVUS LEAD MODEL 5594. THE DEVICE IS INDICATED FOR PACING AN DSENSING IN THE ATRIUM. THE LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.

    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