# OOB · Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

_ ·  · Class 3_

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

## Overview

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

## Identification

A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.  A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion.  A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P230035](https://fda.innolitics.com/submissions/CV/CV-misc/OOB/P230035.md) | AGENT Paclitaxel-Coated Balloon Catheter | Boston Scientific Corporation | Feb 29, 2024 | APPR |

## Top Applicants

- Boston Scientific Corporation — 1 clearance

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

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