BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S014 · Decision Jul 13, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S014
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 13, 2000
    Date Received
    January 27, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE 4.5 AND 5.0 MM DIAMETER NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEMS.