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
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
• ASTM F2079-09 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents¹
• ASTM F 2081-06 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
• AAMI/ANSI/ISO 25539-2:2008 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
• ASTM F 2394-07 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
• ASTM F 2477-07 Standard Test Methods for in vitro Pulsatile Durability
• ASTM F 2514-08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial
• ASTM F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
• AAMI TIR42:2010 Evaluation of Particulates Associated with Vascular Medical Devices

Third Party Review

Not Third Party Eligible