BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960042 · Supplement: S004 · Decision Aug 3, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR
    PMA Number
    P960042
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 3, 1999
    Date Received
    February 17, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits.