BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Tissue Graft Of 6mm And Greater

    PMA: N16837 · Supplement: S034 · Decision Oct 17, 2024
    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
    S034
    Device Class
    FDA Class 3
    Product Code
    LXA
    Generic Name
    Tissue graft of 6mm and greater
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 17, 2024
    Date Received
    September 17, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a larger mixing vessel for the sterilization solution, incorporation of microbial filtration of sterilization solution, and expansion of a cleanroom area

    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