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Aurora EV-ICD System

by Medtronic, Inc.

PMA P220012

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P220012↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP220012 Date20 Oct 2023ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0726-2026 FDA Class II initiated 29 Oct 2025

    There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Aurora EV-ICD
Trade name
Aurora EV-ICD System
Generic name
Implantable cardioverter defibrillator (non-CRT)
PMA number
FDA product code
LWS
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aurora EV-ICD System is an implantable cardioverter defibrillator (non-CRT) designed for the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias. It provides essential cardiac therapies including antitachycardia pacing, cardioversion, and defibrillation to help prevent sudden cardiac death in patients with conditions such as coronary disease, cardiomyopathy, or inherited arrhythmia syndromes.

This system utilizes the Epsila EV MRI SureScan Model EV2401 extravascular lead, which is indicated for placement in the anterior mediastinum. Implantation is supported by the Epsila EV EAZ101 Sternal Tunneling Tool and the Epsila EV EAZ201 Transverse Tunneling Tool. The device has received FDA PMA authorization for clinical use in managing patients at risk of life-threatening arrhythmias.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Aurora EV-ICD System?

    The system is designed to provide automated treatment for life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies.

  • Which patients may be indicated for this device?

    The device is indicated for patients at risk of sudden cardiac death due to conditions such as previous ventricular tachyarrhythmias, coronary disease with left ventricular dysfunction, cardiomyopathy, inherited primary arrhythmia syndromes, or congenital heart disease.

  • What components are used during the implantation of the lead?

    The system uses the Epsila EV MRI SureScan Model EV2401 lead, which is implanted using the Epsila EV EAZ101 Sternal Tunneling Tool and the Epsila EV EAZ201 Transverse Tunneling Tool.