BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960042 · Supplement: S001 · Decision Jun 16, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
    PMA Number
    P960042
    Supplement Number
    S001
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 16, 1998
    Date Received
    December 12, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the 12 French Outer Sheath. The device is an accessory to the 12 French Laser Sheath and will be packaged in the 12 French Laser Sheath Kit.