← Product Code [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY) · K792299

# ARCOLITH 3020-CARDIAC PULSE GENERATOR (K792299)

_Arco Medical Products Co. · DXY · Nov 29, 1979 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K792299

## Device Facts

- **Applicant:** Arco Medical Products Co.
- **Product Code:** [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY.md)
- **Decision Date:** Nov 29, 1979
- **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/K792299](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K792299)

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