BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    PMA: P000058 · Supplement: S081 · Decision Feb 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
    Trade Name
    Infuse Bone Graft/Medtronic Interbody Fusion Device
    PMA Number
    P000058
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    NEK
    Generic Name
    Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 18, 2022
    Date Received
    July 29, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for extension of the expiration date from 18 to 24 months for three 1mg drug product lots manufactured at Hospira, Inc. (McPherson, Kansas) and seven 1mg drug product lots manufactured at Wyeth Farma S.A. (Algete, Spain) when stored at 5° and 30°C; addition of a 30 month timepoint to the long-term stability protocol studies performed at 30 ºC ± 2 ºC /75 ± 5% RH and 30 ºC ± 2 ºC /75 ± 5% RH; and discontinuation of testing at the 5°C long-term storage condition (current 5°C lots will continue to the end of the current study).

    Classifications

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

    Product Code Device Name
    NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction