# NPT · Aortic Valve, Prosthesis, Percutaneously Delivered

_ ·  · Class 3_

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

## Overview

- **Product Code:** NPT
- **Device Name:** Aortic Valve, Prosthesis, Percutaneously Delivered
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **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 (20 of 22)

Showing 20 most recent of 22 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250024](/device/P250024.md) | Trilogy Transcatheter Heart Valve System | JenaValve Technology, Inc. | Mar 17, 2026 | APPR |
| [P130021S174](/device/P130021S174.md) | Evolut PRO+ System, Evolut FX System, Evolut FX+ System | Medtronic, Inc. | Aug 27, 2025 | APPR |
| [P140031S182](/device/P140031S182.md) | Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system | Edwards Lifesciences, LLC | Apr 30, 2025 | APPR |
| [P190023](/device/P190023.md) | Portico Transcatheter Aortic Valve Implantation System | ABBOTT MEDICAL | Sep 17, 2021 | APPR |
| [P140031S125](/device/P140031S125.md) | SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System | Edwards Lifesciences, LLC | May 13, 2021 | APPR |
| [P140031S112](/device/P140031S112.md) | EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System | Edwards Lifesciences, LLC | Sep 9, 2020 | APPR |
| [P140031S085](/device/P140031S085.md) | SAPIEN 3 Ultra transcatheter heart valve | Edwards Lifesciences, LLC | Aug 16, 2019 | APPR |
| [P130021S058](/device/P130021S058.md) | Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System | Medtronic, Inc. | Aug 16, 2019 | APPR |
| [P180029](/device/P180029.md) | LOTUS Edge Valve System | Boston Scientific Corporation | Apr 23, 2019 | APWD |
| [P130021S033](/device/P130021S033.md) | CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System | Medtronic, Inc. | Jul 10, 2017 | APPR |
| [P140031S028](/device/P140031S028.md) | Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 5, 2017 | APPR |
| [P140031S010](/device/P140031S010.md) | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Aug 18, 2016 | APPR |
| [P130009S057](/device/P130009S057.md) | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Aug 18, 2016 | APPR |
| [P130009S037](/device/P130009S037.md) | SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Feb 29, 2016 | APPR |
| [P130009S034](/device/P130009S034.md) | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Oct 9, 2015 | APPR |
| [P140031](/device/P140031.md) | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 17, 2015 | APPR |
| [P130021S010](/device/P130021S010.md) | MEDTRONIC COREVALVE SYSTEM | Medtronic, Inc. | Mar 30, 2015 | APPR |
| [P130009](/device/P130009.md) | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | Edwards Lifesciences, LLC | Jun 16, 2014 | APPR |
| [P130021S002](/device/P130021S002.md) | MEDTRONIC COREVALVE SYSTEM | Medtronic, Inc. | Jun 12, 2014 | APPR |
| [P130021](/device/P130021.md) | MEDTRONIC COREVALVE SYSTEM | Medtronic, Inc. | Jan 17, 2014 | APPR |

## Top Applicants

- Edwards Lifesciences, LLC — 13 clearances
- Medtronic, Inc. — 6 clearances
- ABBOTT MEDICAL — 1 clearance
- Boston Scientific Corporation — 1 clearance
- JenaValve Technology, Inc. — 1 clearance

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

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