BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S009 · Decision Jul 1, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PREMOUNTED STENT SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S009
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 1, 1999
    Date Received
    May 28, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the additional sterilization facility located at Griffith Micro Sciences, Park Industrial De Petit Rechain, Verviers 4800, Belgium.