BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S050 · Decision Jun 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD
    PMA Number
    P890003
    Supplement Number
    S050
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 3, 1998
    Date Received
    May 5, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: Medtronic Models 5038-58, 5038-65, 5038-52, 5038S-58, and 5038L-65 CapSure VDd-2 and Vitatron Models IMW 14Q/15Q/16Q/17Q/18Q Brilliant S+ VDD Pacing Leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current Medtronic(R) VDD pacemakers.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator