# NIK · Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

_ ·  · Class 3_

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

## Overview

- **Product Code:** NIK
- **Device Name:** Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P010031S381](/device/P010031S381.md) | CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES | Medtronic Cardiac Rhythm Disease Management | Apr 10, 2014 | APPR |
| [P010031S232](/device/P010031S232.md) | CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT | Medtronic Cardiac Rhythm Disease Management | Apr 4, 2012 | APPR |
| [P060027](/device/P060027.md) | OVATIO CRT SYSTEM | MicroPort CRM USA, Inc. | May 15, 2008 | APPR |
| [P010012S037](/device/P010012S037.md) | CONTAK RENEWAL 3 AVT CRT-D SYSTEM | Boston Scientific Corp | Mar 13, 2008 | APPR |
| [P030054S010](/device/P030054S010.md) | EPIC AND ATLAS+ HF CRT-D SYSTEMS | ABBOTT MEDICAL | Nov 18, 2005 | APPR |
| [P010012S026](/device/P010012S026.md) | CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A | Boston Scientific Corp | Sep 14, 2004 | APPR |
| [P030054](/device/P030054.md) | ST JUDE MEDICAL EPIC HF SYSTEM | ABBOTT MEDICAL | Jun 30, 2004 | APPR |
| [P010031](/device/P010031.md) | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | Medtronic Cardiac Rhythm Disease Management | Jun 26, 2002 | APPR |
| [P010012](/device/P010012.md) | CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL | Boston Scientific Corp | May 2, 2002 | APPR |

## Top Applicants

- Boston Scientific Corp — 3 clearances
- Medtronic Cardiac Rhythm Disease Management — 3 clearances
- ABBOTT MEDICAL — 2 clearances
- MicroPort CRM USA, Inc. — 1 clearance

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

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