BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S017 · Decision May 5, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
    PMA Number
    P960043
    Supplement Number
    S017
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 5, 1999
    Date Received
    April 2, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the labeling and placement of the outer package label.