BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940031 · Supplement: S010 · Decision Aug 8, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VIGOR(R) DR/SR PACEMAKER SYSTEM
    PMA Number
    P940031
    Supplement Number
    S010
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 8, 1997
    Date Received
    July 18, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).