BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960043 · Supplement: S013 · Decision Dec 7, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S013
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 7, 1998
    Date Received
    November 12, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an alternate sterilization facility located at Griffith Micro Science, Inc. 4900 South Gifford Ave., Los Angeles, CA 90058.