# NIQ · Coronary Drug-Eluting Stent

_ ·  · Class 3_

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

## Overview

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

## Identification

Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.  The drug coating is intended to inhibit restenosis.

## Recent Cleared Devices (20 of 38)

Showing 20 most recent of 38 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150003S105](/device/P150003S105.md) | SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi | Boston Scientific Corporation | Jan 27, 2025 | APPR |
| [P160043S058](/device/P160043S058.md) | Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular | Sep 15, 2022 | APPR |
| [P190020](/device/P190020.md) | BioFreedom Drug Coated Coronary Stent System | Biosensors International USA, Inc. | Apr 14, 2022 | APWD |
| [P210014](/device/P210014.md) | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex | Advanced Bifurcation Systems, Inc. | Dec 13, 2021 | APWD |
| [P110019S115](/device/P110019S115.md) | XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary | Abbott Vascular | Jun 25, 2021 | APPR |
| [P160043S034](/device/P160043S034.md) | Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular | Sep 22, 2020 | APPR |
| [P150003S058](/device/P150003S058.md) | Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) | Boston Scientific Corporation | Aug 10, 2020 | APPR |
| [P170030](/device/P170030.md) | ORSIRO Sirolimus Eluting Coronary Stent System | Biotronik AG | Feb 22, 2019 | APPR |
| [P160043S012](/device/P160043S012.md) | Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular | Dec 14, 2018 | APPR |
| [P110013S088](/device/P110013S088.md) | Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular | Dec 14, 2018 | APPR |
| [P170008](/device/P170008.md) | EluNIR™ Ridaforolimus Eluting Coronary Stent System | Medinol, Ltd. | Nov 28, 2017 | APPR |
| [P160043S001](/device/P160043S001.md) | Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular | Nov 16, 2017 | APPR |
| [P160043](/device/P160043.md) | RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM | Medtronic Vascular | Apr 28, 2017 | APPR |
| [P150003S003](/device/P150003S003.md) | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL) | Boston Scientific Corporation | Jul 29, 2016 | APPR |
| [P150003](/device/P150003.md) | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | Boston Scientific Corporation | Oct 2, 2015 | APPR |
| [P110019S075](/device/P110019S075.md) | XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM | Abbott Vascular | Sep 23, 2015 | APPR |
| [P070015S128](/device/P070015S128.md) | XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM | Abbott Vascular, Inc. | Sep 23, 2015 | APPR |
| [P110010S096](/device/P110010S096.md) | PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE- | Boston Scientific Corp | Jun 1, 2015 | APPR |
| [P110019S066](/device/P110019S066.md) | XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM | Abbott Vascular | Oct 3, 2014 | APPR |
| [P070015S122](/device/P070015S122.md) | XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM | Abbott Vascular, Inc. | Oct 3, 2014 | APPR |

## Top Applicants

- Boston Scientific Corp — 12 clearances
- Medtronic Vascular — 8 clearances
- Abbott Vascular — 4 clearances
- Abbott Vascular, Inc. — 4 clearances
- Boston Scientific Corporation — 4 clearances

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

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