# OAE · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

_ ·  · Class 3_

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

## Overview

- **Product Code:** OAE
- **Device Name:** Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Life-sustaining:** yes

## Identification

For the treatment of atrial fibrillation.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150005S074](/device/P150005S074.md) | INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System | Boston Scientific Corp | Feb 26, 2024 | APPR |
| [P220032](/device/P220032.md) | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | Boston Scientific Corporation | Aug 8, 2023 | APPR |
| [P220013](/device/P220013.md) | TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C | ABBOTT MEDICAL | May 18, 2023 | APPR |
| [P210027](/device/P210027.md) | QDOT MICRO™ System | Biosense Webster, Inc. | Nov 23, 2022 | APPR |
| [P130026S070](/device/P130026S070.md) | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | St Jude Medical | Nov 4, 2021 | APPR |
| [P100010S110](/device/P100010S110.md) | Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter | Medtronic Cryocath, LP | Jun 18, 2021 | APPR |
| [P200028](/device/P200028.md) | DiamondTemp Ablation System | Medtronic, Inc. | Jan 28, 2021 | APPR |
| [P100010S098](/device/P100010S098.md) | Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters | Medtronic Cryocath, LP | Jun 23, 2020 | APPR |
| [P150005S014](/device/P150005S014.md) | Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter | Boston Scientific Corp | Dec 21, 2017 | APPR |
| [P150026](/device/P150026.md) | HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM | Cardiofocus, Inc. | Apr 1, 2016 | APPR |
| [P130026](/device/P130026.md) | TACTICATH QUARTZ SET | St Jude Medical | Oct 24, 2014 | APPR |
| [P100010](/device/P100010.md) | ARCTIC FRONT CRYOCATHETER SYSTEM | Medtronic Cryocath, LP | Dec 17, 2010 | APPR |
| [P030031S011](/device/P030031S011.md) | NAVISTAR & CELSIUS THERMOCOOL CATHETERS | Biosense Webster, Inc. | Feb 6, 2009 | APPR |

## Top Applicants

- Medtronic Cryocath, LP — 3 clearances
- Biosense Webster, Inc. — 2 clearances
- Boston Scientific Corp — 2 clearances
- St Jude Medical — 2 clearances
- ABBOTT MEDICAL — 1 clearance

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

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