Product Classification

• 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 Code: PRL
• 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 Standards

• 3-171 ASTM F2514-21
  Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
• 3-180 ASTM F3505-21
  Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
• 3-189 ASTM F2942-19
  Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
• 3-197 ISO 25539-4 First edition 2021-11
  Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices

Third Party Review

Not Third Party Eligible