BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P890070 · Supplement: S005 · Decision Oct 7, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PURE-DENT B851 ABSORBABLE DUSTING POWDER
    PMA Number
    P890070
    Supplement Number
    S005
    Product Code
    KGP
    Generic Name
    Powder, dusting, surgical
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 2011
    Date Received
    February 17, 2011
    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 PACMOORE PROCESS TECHNOLOGIES, LLC. IN MOORESVILLE, INDIANA.