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U.S. Department of Health and Human Services

Product Classification
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Device stent, iliac vein
Definition A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Physical State A metal scaffold placed via a delivery catheter
Technical Method A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Target Area Iliac vein
Review Panel Cardiovascular
Product CodeQAN
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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