BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000054 · Supplement: S040 · Decision Dec 6, 2013
    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
    S040
    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
    December 6, 2013
    Date Received
    October 25, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE®BONE GRAFT AND IS INDICATED FOR THE FOLLOWING: TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT. INFUSE BONE GRAFT MUST BE APPLIED WITHIN 14 DAYS AFTER THE INITIAL FRACTURE. PROSPECTIVE PATIENTS SHOULD BE SKELETALLY MATURE.

    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