← Product Code [DTA](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA) · K791380

# VA 1000 (K791380)

_Vitatron Medical BV · DTA · Sep 19, 1979 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K791380

## Device Facts

- **Applicant:** Vitatron Medical BV
- **Product Code:** [DTA](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA.md)
- **Decision Date:** Sep 19, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3720
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K791380](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K791380)

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