NPT · Aortic Valve, Prosthesis, Percutaneously Delivered
· Class 3
Overview
| Product Code | NPT |
|---|---|
| Device Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250024 | Trilogy Transcatheter Heart Valve System | JenaValve Technology, Inc. | Mar 17, 2026 | APPR |
| P190023 | Portico Transcatheter Aortic Valve Implantation System | ABBOTT MEDICAL | Sep 17, 2021 | APPR |
| P180029 | LOTUS Edge Valve System | Boston Scientific Corporation | Apr 23, 2019 | APWD |
| P140031 | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 17, 2015 | APPR |
| P130009 | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 16, 2014 | APPR |
| P130021 | MEDTRONIC COREVALVE SYSTEM | Medtronic, Inc. | Jan 17, 2014 | APPR |
| P110021 | EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Oct 19, 2012 | APWD |
| P100041 | EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Nov 2, 2011 | APWD |
Top Applicants
- Edwards Lifesciences, LLC — 4 clearances
- ABBOTT MEDICAL — 1 clearance
- Boston Scientific Corporation — 1 clearance
- JenaValve Technology, Inc. — 1 clearance
- Medtronic, Inc. — 1 clearance
