BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S042 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE
    PMA Number
    P890003
    Supplement Number
    S042
    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
    October 31, 1995
    Date Received
    August 16, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MARKET SOFTWARE (MODEL 9889E) WHICH IS DESIGNED TO PROVIDE PROGRAMMING CAPABILITIES, USING THE ALREADY APPROVED 9790 AND 9790A PROGRAMMERS FOR THREE MODELS OF PULSE GENERATORS AS RELABELED FOR DISTRIBUTION BY ANOTHER COMPANY, CPI UNDER THEIR TRADE NAMES. THE PACEMAKERS ARE: THE LEGEND TO BE RELABELED AS TRIUMPH VR, ELITE TO BE RELABELED AS PRELUDE DR AND SYNERGYST II TO BE RELABELED AS TRIUMPH DR.

    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