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

    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

    PMA: P210006 · Supplement: S011 · Decision Jan 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
    Trade Name
    Thoraflex™ Hybrid
    PMA Number
    P210006
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    QSK
    Generic Name
    Hybrid stent graft, thoracic aortic lesion treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 27, 2025
    Date Received
    December 30, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change to in-process formaldehyde residual testing, a change to tensile test action and warning limits, and a change to the sequence and method of sewing the components of the Thoraflex Hybrid device

    Classifications

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

    Product Code Device Name
    QSK Hybrid Stent Graft, Thoracic Aortic Lesion Treatment