BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S035 · Decision Aug 16, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR CORONARY STENT WITH DELIVERY SYSTEM
    PMA Number
    P980001
    Supplement Number
    S035
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 16, 2001
    Date Received
    July 12, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.