Product Classification

• Device: coronary drug-eluting stent
• Definition: Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
• Review Panel: Cardiovascular
• Product Code: NIQ
• 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: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 3-66 ASTM F2081-06 (Reapproved 2017)
  Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
• 3-79 ASTM F2079-09 (Reapproved 2017)
  Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
• 3-86 ASTM F2394-07 (Reapproved 2017)
  Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
• 3-87 ASTM F2477-07 (Reapproved 2013)
  Standard Test Methods for in vitro Pulsatile Durability
• 3-104 ASTM F2914-12 (Reapproved 2018)
  Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
• 3-138 ASTM F2942-13
  Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
• 3-143 ISO 12417 First edition 2015-10-01
  Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
• 3-171 ASTM F2514-21
  Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
• 3-172 AAMI TIR42:2021
  Evaluation of Particulates Associated with Vascular Medical Devices
• 3-177 ASTM F2606-08 (Reapproved 2021)
  Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
• 3-178 ASTM F3067-14 (Reapproved 2021)
  Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
• 3-181 ISO 25539-2 Third edition 2020-09
  Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
• 3-182 ASTM F3036-21
  Standard Guide for Testing Absorbable Stents
• 3-184 ASTM F2477-23
  Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
• 3-189 ASTM F2942-19
  Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

Guidance Document

• Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies

Third Party Review

Not Third Party Eligible