BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S014 · Decision Dec 21, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S014
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 1998
    Date Received
    November 16, 1998
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding precautions to the Clinical Procedure section of the Instructions for Use regarding suture lumen clamping.