BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S032 · Decision May 29, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PREMOUNTED STENT SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S032
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 29, 2001
    Date Received
    May 7, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REDUCTION OF THE INTERNAL DIAMETER OF THE PROXIMAL SHAFT FROM 0.0205" TO 0.0190" ON THE FOLLOWING PREMOUNTED STENT SYSTEMS: NOROYAL(TM) ADVANCE, NIROYAL(TM) ELITE AND NIR(TM) ELITE.