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U.S. Department of Health and Human Services

Product Classification
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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 CodeQWN
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
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