BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tissue Graft Of 6mm And Greater

    PMA: N16837 · Supplement: S020 · Decision Apr 29, 2015
    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
    S020
    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
    April 29, 2015
    Date Received
    April 1, 2015
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE BROCHURE INCLUDING: 1) CHANGE THE SIZE LABELING CONVENTION FROM OUTER TO INNER DIAMETER; AND 2) THE ADDITION OF AN INFORMATION STATEMENT NOT MADE WITH NATURAL RUBBER LATEX.

    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