BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970061 · Supplement: S003 · Decision Sep 15, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
    PMA Number
    P970061
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 15, 1998
    Date Received
    August 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 Scimed Life Systems, One Scimed Place, Maple Grove, Minnesota.