Product Classification

• Device: stent, coronary
• Definition: The formerly known device, cardiovascular stent, coded as "maf" has been modified and is currently known and classified as a "coronary stent".This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
• Review Panel: Cardiovascular
• Product Code: MAF
• 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

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