BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S018 · Decision Apr 25, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PREMOUNTED STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S018
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 25, 2000
    Date Received
    March 22, 2000
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an addition of a note to the Instructions for Use of the NIR Primo Premounted Stent System.