BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960042 · Supplement: S005 · Decision Mar 17, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SPECTRANETICS LASER SHEATHS (SLS)
    PMA Number
    P960042
    Supplement Number
    S005
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 2000
    Date Received
    September 28, 1999
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.