# LWR · Heart-Valve, Non-Allograft Tissue

_ ·  · Class 3_

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

## Overview

- **Product Code:** LWR
- **Device Name:** Heart-Valve, Non-Allograft Tissue
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P170006](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P170006.md) | AVALUS(TM) BIOPROSTHESIS | Medtronic, Inc. | Jul 31, 2017 | APPR |
| [P150048](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P150048.md) | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) | Edwards Lifesciences, LLC | Jun 29, 2017 | APPR |
| [P150036](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P150036.md) | EDWARDS INTUITY ELITE VALVE SYSTEM | Edwards Lifesciences, LLC | Aug 12, 2016 | APPR |
| [P150011](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P150011.md) | PERCEVAL SUTURELESS HEART VALVE | Corcym S.r.l. | Jan 8, 2016 | APPR |
| [P130011](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P130011.md) | FREEDOM SOLO STENTLESS HEART VALVE | Corcym Canada Corp | Jun 24, 2014 | APWD |
| [P100029](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P100029.md) | ST JUDE MEDICAL TRIFECTA VALVE | ABBOTT MEDICAL | Apr 20, 2011 | APPR |
| [P060025](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P060025.md) | ATS 3F AORTIC BIOPROSTHESIS | Medtronic, Inc. | Oct 30, 2008 | APWD |
| [P060038](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P060038.md) | MITROFLOW AORTIC PERICARDIAL HEART VALVE | Corcym Canada Corp | Oct 23, 2007 | APWD |
| [P040021](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P040021.md) | SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE | ABBOTT MEDICAL | Aug 5, 2005 | APPR |
| [P970031](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P970031.md) | MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS | Medtronic, Inc. | Nov 26, 1997 | APPR |
| [P970030](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P970030.md) | TORONTO SPV VALVE | St. Jude Medical, Inc. | Nov 4, 1997 | APWD |
| [P790007](https://fda.innolitics.com/submissions/CV/CV-misc/LWR/P790007.md) | HANCOCK MODIFIED ORIFICE BIOPROSTHESIS | Medtronic Heart Valves | Nov 15, 1979 | APPR |

## Top Applicants

- Medtronic, Inc. — 3 clearances
- ABBOTT MEDICAL — 2 clearances
- Corcym Canada Corp — 2 clearances
- Edwards Lifesciences, LLC — 2 clearances
- Corcym S.r.l. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com