← Product Code [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY) · K831771

# IMPLANTABLE PROGRAM. CARDIAC PULSE GEN (K831771)

_Telectronics, Inc. · DXY · Aug 16, 1983 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K831771

## Device Facts

- **Applicant:** Telectronics, Inc.
- **Product Code:** [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY.md)
- **Decision Date:** Aug 16, 1983
- **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/K831771](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K831771)

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