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