BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P000054 · Supplement: S059 · Decision Jul 10, 2020
    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
    S059
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 10, 2020
    Date Received
    June 11, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Optimization of the pre-sterilization phase set points of in-process autoclave cycles and addition of a second Tyvek wrapping for equipment, parts, and components sterilized in the in-process autoclaves.

    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