# LWS · Implantable Cardioverter Defibrillator (Non-Crt)

_ ·  · Class 3_

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

## Overview

- **Product Code:** LWS
- **Device Name:** Implantable Cardioverter Defibrillator (Non-Crt)
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

## Recent Cleared Devices (17 of 17)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P220012](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P220012.md) | Aurora EV-ICD System | Medtronic, Inc. | Oct 20, 2023 | APPR |
| [P110042](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P110042.md) | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM | Boston Scientific Corporation | Sep 28, 2012 | APPR |
| [P980050](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P980050.md) | MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF | Medtronic, Inc. | Jun 14, 2000 | APPR |
| [P980023](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P980023.md) | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | Biotronik, Inc. | Oct 27, 1998 | APPR |
| [P980016](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P980016.md) | VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS | Medtronic Cardiac Rhythm Disease Management | Oct 9, 1998 | APPR |
| [P970024](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P970024.md) | ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. | MicroPort CRM USA, Inc. | Aug 19, 1998 | APWD |
| [P960040](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P960040.md) | VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM | Boston Scientific | Jul 18, 1997 | APPR |
| [P940024](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P940024.md) | GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. | Telectronics Pacing Systems, Inc. | Jul 3, 1997 | APPR |
| [P950022](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P950022.md) | TVL(TM) LEAD SYSTEM | ABBOTT MEDICAL | May 10, 1996 | APPR |
| [P940008](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P940008.md) | RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS | Boston Scientific | Nov 28, 1995 | APWD |
| [P930035](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P930035.md) | VENTAK(R) P2 SYSTEM | Boston Scientific | Mar 10, 1995 | APPR |
| [P910077](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P910077.md) | VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR | Boston Scientific | Jun 17, 1994 | APPR |
| [P910073](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P910073.md) | ENDOTAK LEAD SYSTEM | Boston Scientific | Aug 26, 1993 | APPR |
| [P910023](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P910023.md) | CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM | ABBOTT MEDICAL | Apr 30, 1993 | APPR |
| [P900061](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P900061.md) | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM | Medtronic Cardiac Rhythm Disease Management | Feb 11, 1993 | APPR |
| [P890061](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P890061.md) | VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE | Boston Scientific | May 2, 1991 | APPR |
| [P830060](https://fda.innolitics.com/submissions/CV/CV-misc/LWS/P830060.md) | VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS | Boston Scientific | Oct 4, 1985 | APPR |

## Top Applicants

- Boston Scientific — 7 clearances
- ABBOTT MEDICAL — 2 clearances
- Medtronic Cardiac Rhythm Disease Management — 2 clearances
- Medtronic, Inc. — 2 clearances
- Biotronik, Inc. — 1 clearance

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

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