Device |
stent graft, infrapopliteal, venous arterialization |
Definition |
For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs |
Physical State |
Covered metal scaffold, catheter delivery system, and accessories |
Technical Method |
A covered metal scaffold placed via delivery catheter(s) and accessories to arterialize the deep veins in the lower limb |
Target Area |
Infrapopliteal vessels |
Review Panel |
Cardiovascular |
Product Code | QWN |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
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 |