BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970061 · Supplement: S007 · Decision Sep 17, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SCIMED RADIUS CORONARY STENT
    PMA Number
    P970061
    Supplement Number
    S007
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 17, 1999
    Date Received
    April 20, 1999
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a centerless grinding process to widen trace element nitinol tubing material.