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U.S. Department of Health and Human Services

Product Classification

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Device hybrid stent graft, thoracic aortic lesion treatment
Definition Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Physical State Combination of vascular grafts and/or stent grafts
Technical Method An open surgical procedure in which a vascular graft and/or stent graft is placed inside the thoracic aorta, redirecting blood flow away from the lesion and replacing or relining the aortic wall.
Target Area Ascending Aorta, Aortic Arch and Descending Thoracic Aorta
Review Panel Cardiovascular
Product CodeQSK
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible