BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980001 · Supplement: S037 · Decision Sep 20, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR PREMOUNTED STENT DELIVERY SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S037
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 20, 2001
    Date Received
    August 1, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES FOR PACKAGING AND LABELING LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY MASSACHUSETTS AND BOSON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.