← Product Code [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY) · K905403

# MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (K905403)

_Cook Pacemaker Corp. · DXY · Oct 16, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K905403

## Device Facts

- **Applicant:** Cook Pacemaker Corp.
- **Product Code:** [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY.md)
- **Decision Date:** Oct 16, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3610
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K905403](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K905403)

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