BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S048 · Decision Nov 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE
    PMA Number
    P890003
    Supplement Number
    S048
    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
    November 19, 1996
    Date Received
    October 22, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO COMMERCIALLY DISTRIBUTE THE MEDTRONIC PREVA ST DR MODEL 7078 AND PREVA D MODEL 7068 PULSE GENERATORS; AND THE MODEL 9959 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