BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000054 · Supplement: S052 · Decision Jan 15, 2019
    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
    S052
    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
    January 15, 2019
    Date Received
    October 17, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an additional 6000 L bioreactor to be located in Building B, Suite C/D at the Andover site.

    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