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U.S. Department of Health and Human Services

Product Classification

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Device stent, iliac
Definition Stent, iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen.
Review Panel Cardiovascular
Product CodeNIO
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
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
Third Party Review Not Third Party Eligible
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