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U.S. Department of Health and Human Services

Product Classification
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Device stent graft, bypass, superficial femoral artery
Definition For bypassing stenosis in the superficial femoral artery via the femoral vein
Physical State Covered metal stent, catheter delivery system, crossing catheter, and accessories
Technical Method A covered metal scaffold placed via delivery catheter(s) and accessories to bypass the superficial femoral artery via the femoral vein
Target Area Upper leg vessels
Review Panel Cardiovascular
Product CodeQWM
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? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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