BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940008 · Supplement: S008 · Decision Dec 29, 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
    S008
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 29, 1997
    Date Received
    November 26, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to the IS-1 connector of the existing defibrillation/pacing leads.