# PRL · Iliac Covered Stent, Arterial

_ ·  · Class 3_

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

## Overview

- **Product Code:** PRL
- **Device Name:** Iliac Covered Stent, Arterial
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

For the treatment of de novo or restenotic lesions found in iliac arteries

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P120003](https://fda.innolitics.com/submissions/CV/CV-misc/PRL/P120003.md) | iCast Covered Stent System | Atrium Medical Corp. | Mar 22, 2023 | APPR |
| [P160024](https://fda.innolitics.com/submissions/CV/CV-misc/PRL/P160024.md) | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT | Bard Peripheral Vascular, Inc. | Apr 24, 2017 | APPR |
| [P160021](https://fda.innolitics.com/submissions/CV/CV-misc/PRL/P160021.md) | GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Jan 27, 2017 | APPR |

## Top Applicants

- Atrium Medical Corp. — 1 clearance
- Bard Peripheral Vascular, Inc. — 1 clearance
- W. L. Gore & Associates, Inc. — 1 clearance

---

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

**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