BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990017 · Supplement: S004 · Decision Jan 7, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ANCURE(TM) ENDOGRAFT(R) SYSTEM
    PMA Number
    P990017
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 7, 2000
    Date Received
    December 14, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes under 21 CFR 814.39(d)