BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S043 · Decision Jul 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS
    PMA Number
    P890003
    Supplement Number
    S043
    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
    July 1, 1996
    Date Received
    February 9, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MARKETING OF A SUBSET OF PULSE GENERATROS FROM THE APPROVED THERA-I/PRODIGY HARDWARE AND SOFTWARE PLATFORMS. THE DEVICES AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:MEDTRONIC:THERA MODEL 7968I PULSE GENERATOR; PRODIGY MODEL 8158 PULSE GENERATOR; PREVA MODELS 7088, 7089, 8088, AND 8089 PULSE GENERATORS; MODELS 9898E AND 9899E SOFTWARE - VITATRON:LEGACY II MODELS 126/128/526/528/726/728/826/828 PULSE GENERATORS; VISA MODELS 115/116/415/416/425/426/435/436 PULSE GENERATORS; AND MODEL 9849E SOFTWARE

    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