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 |
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 Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
Yes
|
Third Party Review |
Not Third Party Eligible |