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U.S. Department of Health and Human Services

Product Classification

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Device endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Definition Endovascular repair of thoracoabdominal and pararenal aortic lesions
Physical State The endovascular system is a metal scaffold which may or may not be covered with fabric material. The permanent implant is placed via a delivery catheter into the aorta and its branching vessels.
Technical Method An endovascular procedure in which a single component or multiple components of the device system are delivered into the aorta and branching vessels via catheters inserted through small incisions in the arteries of the arm and leg. These components redirect blood flow to treat the lesion.
Target Area Segment of the aorta bridging across the diaphragm from the chest through the abdomen involving the renal arteries and visceral branch vessels. More proximal and/or more distal anatomy may also be involved.
Review Panel Cardiovascular
Product CodeQZK
Premarket Review Office of Cardiovascular Devices (OHT2)
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? No
Third Party Review Not Third Party Eligible