# NKE · Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

_ ·  · Class 3_

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

## Overview

- **Product Code:** NKE
- **Device Name:** Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P070008](https://fda.innolitics.com/submissions/CV/CV-misc/NKE/P070008.md) | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD | Biotronik, Inc. | May 12, 2008 | APPR |
| [P030035](https://fda.innolitics.com/submissions/CV/CV-misc/NKE/P030035.md) | ANTHEM AND FRONTIER II CRT-P'S | ABBOTT MEDICAL | May 13, 2004 | APPR |
| [P030005](https://fda.innolitics.com/submissions/CV/CV-misc/NKE/P030005.md) | CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE | Guidant Corp. | Jan 26, 2004 | APPR |

## Top Applicants

- ABBOTT MEDICAL — 1 clearance
- Biotronik, Inc. — 1 clearance
- Guidant Corp. — 1 clearance

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

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