BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S020 · Decision Sep 16, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR XL 6 FR. PERCUTANEOUS VASCULAR SURGICAL DEVICES
    PMA Number
    P960043
    Supplement Number
    S020
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 16, 1999
    Date Received
    July 23, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the manufacture and quality control of the Techstar(R) XL PVS System.