BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P100006 · Supplement: S006 · Decision Sep 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    AUGMENT Bone Graft and AUGMENT Injectable
    PMA Number
    P100006
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    NOX
    Generic Name
    Filler, bone void, synthetic peptide
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 26, 2018
    Date Received
    July 2, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an alternate secondary packaging configuration for AUGMENT Injectable and corresponding changes in the AUGMENT Injectable package insert and surgical technique guide reflecting this alternate packaging configuration; re-design of the AUGMENT Injectable kit carton to accommodate a pouch in pouch configuration; and modifications to the payload area and the number of frozen gel packs utilized in the approved shipping unit for both AUGMENT Injectable and AUGMENT Bone Graft.

    Classifications

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

    Product Code Device Name
    NOX Filler, Bone Void, Synthetic Peptide