# MIH · System, Endovascular Graft, Aortic Aneurysm Treatment

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/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 34)

Showing 20 most recent of 34 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020018S064](/device/P020018S064.md) | Zenith® Iliac Branch | Cook, Inc. | May 30, 2025 | APPR |
| [P200030S014](/device/P200030S014.md) | GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) | W. L. Gore and Associates, Inc. | Apr 5, 2024 | APPR |
| [P200045S002](/device/P200045S002.md) | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | Mar 7, 2023 | APPR |
| [P210032](/device/P210032.md) | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) | W. L. Gore & Associates, Inc. | May 13, 2022 | APPR |
| [P200045](/device/P200045.md) | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | Aug 5, 2021 | APPR |
| [P200030](/device/P200030.md) | Gore Excluder Conformable AAA Endoprosthesis (CEXC) | W. L. Gore and Associates, Inc. | Dec 22, 2020 | APPR |
| [P190015](/device/P190015.md) | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | May 4, 2020 | APPR |
| [P120006S031](/device/P120006S031.md) | Alto Abdominal Stent Graft System | Endologix, LLC | Mar 13, 2020 | APPR |
| [P180001](/device/P180001.md) | Zenith Dissection Endovascular System | William Cook Europe Aps | Dec 31, 2018 | APPR |
| [P150002](/device/P150002.md) | INCRAFT(R) AAA STENT GRAFT SYSTEM | Cordis US Corporation | Nov 27, 2018 | APWD |
| [P100040S036](/device/P100040S036.md) | Valiant Navion Thoracic Stent Graft System | Medtronic Vascular | Oct 19, 2018 | APPR |
| [P100021S063](/device/P100021S063.md) | Endurant II/IIs Stent Graft System | Medtronic Vascular | Sep 29, 2017 | APPR |
| [P020004S123](/device/P020004S123.md) | GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Feb 29, 2016 | APPR |
| [P140016](/device/P140016.md) | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT | Cook Medical Incorporated | Sep 15, 2015 | APPR |
| [P100040S012](/device/P100040S012.md) | VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM | Medtronic Vascular | Jan 22, 2014 | APPR |
| [P040043S051](/device/P040043S051.md) | GORE TAG THORACIC ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Sep 10, 2013 | APPR |
| [P110032](/device/P110032.md) | AORFIX FLEXIBLE STENT GRAFT SYSTEM | Lombard Medical Limited | Feb 14, 2013 | APWD |
| [P100040S008](/device/P100040S008.md) | VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM | Medtronic Vascular | Oct 26, 2012 | APPR |
| [P120006](/device/P120006.md) | OVATION ABDOMINAL STENT GRAFT SYSTEM | Endologix, LLC | Oct 5, 2012 | APPR |
| [P110038](/device/P110038.md) | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | Bolton Medical, Inc. | Sep 21, 2012 | APPR |

## Top Applicants

- Medtronic Vascular — 9 clearances
- W. L. Gore & Associates, Inc. — 6 clearances
- Bolton Medical, Inc. — 4 clearances
- Cook, Inc. — 3 clearances
- Endologix, LLC — 3 clearances

---

**Source:** [https://fda-staging.innolitics.com/productcode/MIH](https://fda-staging.innolitics.com/productcode/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