Product Classification

• 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 Code: QSK
• 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 Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standard

• 3-197 ISO 25539-4 First edition 2021-11
  Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices

Third Party Review

Not Third Party Eligible