# ONU · Drug-Eluting Peripheral Transluminal Angioplasty Catheter

_ ·  · Class 3_

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

## Overview

- **Product Code:** ONU
- **Device Name:** Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210025](https://fda.innolitics.com/submissions/CV/CV-misc/ONU/P210025.md) | SurVeil Drug-Coated Balloon | Surmodics,Inc. | Jun 16, 2023 | APPR |
| [P210039](https://fda.innolitics.com/submissions/CV/CV-misc/ONU/P210039.md) | Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) | Trireme Medical, LLC | Nov 4, 2022 | APPR |
| [P190019](https://fda.innolitics.com/submissions/CV/CV-misc/ONU/P190019.md) | Ranger™ Paclitaxel-Coated PTA Balloon Catheter | Boston Scientific Corporation | Oct 30, 2020 | APPR |
| [P160049](https://fda.innolitics.com/submissions/CV/CV-misc/ONU/P160049.md) | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON | The Spectranetics Corp. | Jul 26, 2017 | APPR |
| [P140010](https://fda.innolitics.com/submissions/CV/CV-misc/ONU/P140010.md) | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and  IN.PACT 018 Paclitax | Medtronic, Inc. | Dec 30, 2014 | APPR |
| [P130024](https://fda.innolitics.com/submissions/CV/CV-misc/ONU/P130024.md) | LUTONIX DRUG COATED BALLOON PTA CATETER | Lutonix | Oct 9, 2014 | APPR |

## Top Applicants

- Boston Scientific Corporation — 1 clearance
- Lutonix — 1 clearance
- Medtronic, Inc. — 1 clearance
- Surmodics,Inc. — 1 clearance
- The Spectranetics Corp. — 1 clearance

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

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