BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S010 · Decision Dec 21, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S010
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 1998
    Date Received
    August 3, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval to expand the range of users of the Prostar(R) and Techstar(R) PVS systems to inlcude healthcare professionals other than physicians.