BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P050053 · Supplement: S034 · Decision Apr 24, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INFUSE BONE GRAFT
    PMA Number
    P050053
    Supplement Number
    S034
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 24, 2015
    Date Received
    October 27, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A., IN MADRID, SPAIN.