Product Classification

• Device: system, endovascular graft, aortic aneurysm treatment
• Review Panel: Cardiovascular
• Product Code: MIH
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• 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

• 3-104 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
• 3-149 ISO 25539-1 Second edition 2017-02
  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
• 3-157 AAMI ANSI ISO 25539-1: 2017
  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
• 3-162 ASTM F3374-19
  Standard Guide for Active Fixation Durability of Endovascular Prostheses
• 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
• 3-180 ASTM F3505-21
  Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
• 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

Third Party Review

Not Third Party Eligible