BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P980001 · Supplement: S020 · Decision Jun 13, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM
    PMA Number
    P980001
    Supplement Number
    S020
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 13, 2000
    Date Received
    May 26, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN MANUFACTURING PROCESS TO REMOVE TWO INSPECTION STEPS FOR MARKERBAND PLACEMENT ON THE NIR(TM) W/SOX(TM) PREMOUNTED STENT DELIVERY SYSTEM.