# NIU · Stent, Superficial Femoral Artery, Drug-Eluting

_ ·  · Class 3_

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

## Overview

- **Product Code:** NIU
- **Device Name:** Stent, Superficial Femoral Artery, Drug-Eluting
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen.  The drug coating is intended to inhibit restenosis.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P180011](https://fda.innolitics.com/submissions/CV/CV-misc/NIU/P180011.md) | Eluvia Drug-Eluting Vascular Stent System | Boston Scientific Corp | Sep 18, 2018 | APPR |
| [P100022](https://fda.innolitics.com/submissions/CV/CV-misc/NIU/P100022.md) | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | Cook Ireland, Ltd. | Nov 14, 2012 | APPR |

## Top Applicants

- Boston Scientific Corp — 1 clearance
- Cook Ireland, Ltd. — 1 clearance

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

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