BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S012 · Decision Mar 20, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PREMOUNTED STENT SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S012
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 20, 2000
    Date Received
    September 20, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modification to the Indications for Use statement and the Instructions for Use (IFU) to include the results of the nine-month follow-up of the NIRVANA clinical trial for the NIR ON Ranger and NIR Primo Premounted Stent Systems.