BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Graft Of 6mm And Greater

    PMA: N16837 · Supplement: S009 · Decision May 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Tissue Graft Of 6mm And Greater
    Trade Name
    ARTEGRAFT COLLAGEN VASCULAR GRAFT
    PMA Number
    N16837
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    LXA
    Generic Name
    Tissue graft of 6mm and greater
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 11, 2012
    Date Received
    December 28, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER OF A MAJOR COMPONENT FOR THE MANUFACTURING OF THE DEVICE.

    Classifications

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

    Product Code Device Name
    LXA Tissue Graft Of 6mm And Greater