| Device |
endovascular system for treatment of ascending aorta and aortic arch lesions |
| Definition |
Endovascular Repair of Ascending Aorta and Aortic Arch 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 either into the aorta alone or 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 either into the aorta alone or into the aorta and its 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 |
Ascending Aorta, Aortic Arch and Descending Thoracic Aorta |
| Review Panel |
Cardiovascular |
|---|
| Product Code | SDZ |
|---|
| 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? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
