BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S021 · Decision Jul 14, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR(R) PREMOUNTER STENT SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S021
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 14, 2000
    Date Received
    June 30, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE CONTRACT STERILIZATION FACILITY LOCATED AT IBA (FORMERLY GRIFFITH MICRO SCIENCE, INC.), WILLOWBROOK, ILLINOIS.