BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

    PMA: P000054 · Supplement: S016 · Decision Mar 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
    Trade Name
    INFUSE BONE GRAFT
    PMA Number
    P000054
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MPW
    Generic Name
    Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 2008
    Date Received
    November 16, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INCLUSION OF A WARNING RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION IN THE PACKAGE INSERT. THE INCLUSION OF THIS ADDITIONAL WARNING WAS PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction