BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970061 · Supplement: S001 · Decision Feb 4, 1999
    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
    S001
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 4, 1999
    Date Received
    August 10, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modification ot the indications statement to include the treatment of saphenous vein graft lesions. The SCIMED RADIUS(TM) Coronary Stent (14 mm and 20 mm lengths) with Delivery System is indicated for use in patients with symptomaitc ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diamter ranging from 2.75 to 4.25 mm and is intended to improve coronary luminial diameter.