BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

    PMA: P210006 · Decision Apr 19, 2022
    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
    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
    April 19, 2022
    Date Received
    February 25, 2021
    Expedited Review
    N
    Docket Number
    22M-0632

    Advisory Committee Statement

    Approval for the Thoraflex Hybrid. The device is intended for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta in cases of aneurysm and/or dissection.

    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