BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S001 · Decision May 20, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PRIMO PREMOUNTED STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S001
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 20, 1999
    Date Received
    August 25, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the NIR Primo Premounted Stent System.