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U.S. Department of Health and Human Services

Product Classification

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Device iliac covered stent, arterial
Definition For the treatment of de novo or restenotic lesions found in iliac arteries
Physical State Metallic tube with graft covering
Technical Method Physical mesh tube placed in the vessel to hold open
Target Area Iliac arteries
Review Panel Cardiovascular
Product CodePRL
Premarket Review 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
Third Party Review Not Third Party Eligible
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