BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S022 · Decision Feb 16, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S022
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 16, 2001
    Date Received
    July 13, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE NIROYAL(TM) ELITE OTW STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS IN NATIVE CORONARY ARTERIES (LENTH <=25 MM) IN REFERENCE VESSEL DIAMETER 3.0 TO 4.0 MM; 2) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND 3) PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <=30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.