BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S037 · 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
    MEDTRONIC(R) THERA(TM) PULSE GENERATORS
    PMA Number
    P890003
    Supplement Number
    S037
    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
    April 6, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFIED REDUCED SIZE VERSIONS OF THE THERA DR (APPROVED UNDER P890003/S31). THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME:MEDTRONIC THERA-I SERIES AND PRODIGY PULSE GENERATORS, MODEL 9879 SOFTWARE, AND MODELS 9759/9772 MEMORYMODS.

    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