Product Classification

• Device: stent, superficial femoral artery, drug-eluting
• Definition: Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
• Review Panel: Cardiovascular
• Product Code: NIU
• 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?: Yes

Recognized Consensus Standards

• 3-143 ISO 12417-1 First edition 2015-10-01
  Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
• 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
• 3-193 ISO 12417-1 Second edition 2024-02
  Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
• 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