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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 Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible