# MIH · System, Endovascular Graft, Aortic Aneurysm Treatment

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/MIH

## Overview

- **Product Code:** MIH
- **Device Name:** System, Endovascular Graft, Aortic Aneurysm Treatment
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (20 of 21)

Showing 20 most recent of 21 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210032](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P210032.md) | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) | W. L. Gore & Associates, Inc. | May 13, 2022 | APPR |
| [P200045](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P200045.md) | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | Aug 5, 2021 | APPR |
| [P200030](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P200030.md) | Gore Excluder Conformable AAA Endoprosthesis (CEXC) | W. L. Gore and Associates, Inc. | Dec 22, 2020 | APPR |
| [P190015](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P190015.md) | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | May 4, 2020 | APPR |
| [P180001](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P180001.md) | Zenith Dissection Endovascular System | William Cook Europe Aps | Dec 31, 2018 | APPR |
| [P150002](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P150002.md) | INCRAFT(R) AAA STENT GRAFT SYSTEM | Cordis US Corporation | Nov 27, 2018 | APWD |
| [P140016](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P140016.md) | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT | Cook Medical Incorporated | Sep 15, 2015 | APPR |
| [P110032](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P110032.md) | AORFIX FLEXIBLE STENT GRAFT SYSTEM | Lombard Medical Limited | Feb 14, 2013 | APWD |
| [P120006](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P120006.md) | OVATION ABDOMINAL STENT GRAFT SYSTEM | Endologix, LLC | Oct 5, 2012 | APPR |
| [P110038](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P110038.md) | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | Bolton Medical, Inc. | Sep 21, 2012 | APPR |
| [P100040](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P100040.md) | VALIANT THORACIC STENT GRAFT SYSTEM | Medtronic Vascular | Apr 1, 2011 | APPR |
| [P100021](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P100021.md) | MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM | Medtronic Vascular | Dec 16, 2010 | APPR |
| [P070007](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P070007.md) | TALENT THORACIC STENT GRAFT SYSTEM | Medtronic Vascular | Jun 5, 2008 | APWD |
| [P070016](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P070016.md) | ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM | William Cook Europe Aps | May 21, 2008 | APWD |
| [P070027](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P070027.md) | THE TALENT ABDOMINAL STENT GRAFT SYSTEM | Medtronic Vascular | Apr 15, 2008 | APWD |
| [P040043](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P040043.md) | GORE TAG THORACIC ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Mar 23, 2005 | APPR |
| [P040002](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P040002.md) | ENDOLOGIX POWERLINK SYSTEM | Endologix, LLC | Oct 29, 2004 | APPR |
| [P020018](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P020018.md) | ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM | Cook, Inc. | May 23, 2003 | APPR |
| [P020004](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P020004.md) | EXCLUDER BIFURCATED ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Nov 6, 2002 | APPR |
| [P990020](https://fda.innolitics.com/submissions/CV/CV-misc/MIH/P990020.md) | ANEURX STENT GRAFT SYSTEM | Medtronic Vascular | Sep 28, 1999 | APWD |

## Top Applicants

- Medtronic Vascular — 5 clearances
- Bolton Medical, Inc. — 3 clearances
- W. L. Gore & Associates, Inc. — 3 clearances
- Endologix, LLC — 2 clearances
- William Cook Europe Aps — 2 clearances

---

**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/MIH](https://fda.innolitics.com/submissions/CV/CV-misc/MIH)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com