BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Graft Of 6mm And Greater

    PMA: N16837 · Supplement: S010 · Decision Feb 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Tissue Graft Of 6mm And Greater
    Trade Name
    ARTEGRAFT COLLEGEN VASCULAR GRAFT
    PMA Number
    N16837
    Supplement Number
    S010
    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
    February 25, 2013
    Date Received
    September 24, 2012
    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 MAVERICK BIOSCIENCES PTY LTD AS AN ALTERNATE SUPPLIER OR SOURCE OF THE BOVINE CAROTID ARTERY IN ARTEGRAFT COLLAGEN VASCULAR GRAFT.

    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