BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940008 · Supplement: S005 · Decision Apr 25, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    RES-Q(TM) MICRON ICD SYSTEM
    PMA Number
    P940008
    Supplement Number
    S005
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 25, 1997
    Date Received
    March 24, 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 531-30 RX2000 GRAPHICS PROGRAM MODULE