BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970061 · Supplement: S009 · Decision Aug 22, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT
    PMA Number
    P970061
    Supplement Number
    S009
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 22, 2000
    Date Received
    July 17, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC/SCIMED, INC., PLYMOUTH, MINNESOTA 55442 AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA, WILLOWBROOK, ILLINOIS 60521.