BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960042 · Supplement: S006 · Decision Jan 17, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    LASER SHEATH
    PMA Number
    P960042
    Supplement Number
    S006
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 17, 2001
    Date Received
    August 11, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN INCREASE IN THE LASER "ON" TIME TO 10 SECONDS AND A DECREASE IN THE LASER "OFF" TIME TO 5 SECONDS. THESE DEVICES ARE INDICATED FOR USE AS AN ADJUNCT TO CONVENTIONAL LEAD EXTRACTION TOOLS IN PATIENTS SUITABLE FOR TRANSVENOUS REMOVAL OF CHRONICALLY IMPLANTED PACING OR DEFIBRILLATOR LEADS CONSTRUCTED WITH SILICONE OR POLYURETHANE OUTER INSULATION.