# MLV · Transcatheter Septal Occluder

_ ·  · Class 3_

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

## Overview

- **Product Code:** MLV
- **Device Name:** Transcatheter Septal Occluder
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

Approved PMA:  P000039

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P120021](https://fda.innolitics.com/submissions/CV/CV-misc/MLV/P120021.md) | AMPLATZER PFO OCCLUDER | ABBOTT MEDICAL | Oct 28, 2016 | APPR |
| [P040040](https://fda.innolitics.com/submissions/CV/CV-misc/MLV/P040040.md) | AMPLATZER MUSCULAR VSD OCCLUDER | ABBOTT MEDICAL | Sep 7, 2007 | APPR |
| [P050006](https://fda.innolitics.com/submissions/CV/CV-misc/MLV/P050006.md) | GORE HELEX  SEPTAL OCCLUDER | W. L. Gore & Associates, Inc. | Aug 11, 2006 | APPR |
| [P000049](https://fda.innolitics.com/submissions/CV/CV-misc/MLV/P000049.md) | CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD | Nmt Medical, Inc. | Dec 5, 2001 | APPR |
| [P000039](https://fda.innolitics.com/submissions/CV/CV-misc/MLV/P000039.md) | THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM | ABBOTT MEDICAL | Dec 5, 2001 | APPR |

## Top Applicants

- ABBOTT MEDICAL — 3 clearances
- Nmt Medical, Inc. — 1 clearance
- W. L. Gore & Associates, Inc. — 1 clearance

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

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