

# NGV · System, Appendage Closure, Left Atrial

_ ·  · Class 3_

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

## Overview

- **Product Code:** NGV
- **Device Name:** System, Appendage Closure, Left Atrial
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P130013S074](/device/P130013S074.md) | WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli | Boston Scientific Corp | Jul 16, 2025 | APPR |
| [P200049](/device/P200049.md) | Amplatzer Amulet Left Atrial Appendage Occluder | ABBOTT MEDICAL | Aug 14, 2021 | APPR |
| [P130013S035](/device/P130013S035.md) | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device | Boston Scientific Corp | Jul 21, 2020 | APPR |
| [P130013](/device/P130013.md) | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY | Boston Scientific Corp | Mar 13, 2015 | APPR |

## Top Applicants

- Boston Scientific Corp — 3 clearances
- ABBOTT MEDICAL — 1 clearance

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

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