BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S012 · Decision Feb 19, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR/PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S012
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 19, 1999
    Date Received
    October 19, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Perclose, Inc., 400 Saginaw Dr., Redwood City, CA.