BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

    PMA: P210006 · Supplement: S010 · Decision Mar 28, 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
    S010
    Device Class
    FDA Class 3
    Product Code
    QSK
    Generic Name
    Hybrid stent graft, thoracic aortic lesion treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 28, 2025
    Date Received
    July 10, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in the supplier of the bovine gelatin used to impregnate the grafts, implementation of a new sterilization suite, delivery system material changes, shelf-life updates, and other manufacturing changes.

    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