Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3720](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3720) → DTA — Tester, Pacemaker Electrode Function

# DTA · Tester, Pacemaker Electrode Function

_Cardiovascular · 21 CFR 870.3720 · Class 2_

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

## Overview

- **Product Code:** DTA
- **Device Name:** Tester, Pacemaker Electrode Function
- **Regulation:** [21 CFR 870.3720](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3720)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K163008](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K163008.md) | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | Feb 28, 2017 | SESE |
| [K101982](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K101982.md) | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | St Jude Medical, Crmd | Dec 21, 2010 | SESE |
| [K073230](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K073230.md) | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Biotronik, Inc. | Dec 20, 2007 | SESE |
| [K050884](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K050884.md) | ADAPTER CABLE | Remington Medical, Inc. | May 19, 2005 | SESE |
| [K033613](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K033613.md) | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | Dec 8, 2003 | SESE |
| [K022360](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K022360.md) | ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. | Biotronik, Inc. | Jan 27, 2003 | SESE |
| [K933069](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K933069.md) | MODEL EP-2 CLINICAL STIMULATOR | Ep Medical, Inc. | Oct 21, 1993 | SESE |
| [K812104](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K812104.md) | SIEMENS-ELEMA PSA 376 | Siemens Corp. | Dec 2, 1981 | SESE |
| [K791380](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K791380.md) | VA 1000 | Vitatron Medical BV | Sep 19, 1979 | SESE |
| [K790503](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K790503.md) | CARDIOTEST 2200 | Cardiac Pacemakers, Inc. | May 17, 1979 | SESE |

## Top Applicants

- Biotronik, Inc. — 3 clearances
- Cardiac Pacemakers, Inc. — 1 clearance
- Ep Medical, Inc. — 1 clearance
- Medtronic, Inc. — 1 clearance
- Remington Medical, Inc. — 1 clearance

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

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