HSA · registration DE0510255Medtronic Aurora EV-ICD MRI SureScan™
- Registration number
- DE0510255
- Model name
- Aurora EV-ICD™ MRI SureScan; Epsila EV™ Sternal Tunneling Tool; Epsila EV™ Transverse Tunneling Tool; Epsila EV™ MRI SureScan™ Lead; Epsila EV™ MRI SureScan™ Lead; Aurora EV-ICD™ MRI SureScan Programmer Software
- Model identifier
- DVEA3E4; EAZ101; EAZ201; EV240152; EV240163; SW041
- Registration date
- January 17, 2025
- Source update date
- June 11, 2025
- Risk class
- Class D
- Product owner
- Medtronic, Inc
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
The Aurora EV-ICD MRI SureScan Model DVEA3E4 device is indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. Medical conditions that may indicate a patient for an EV-ICD for primary or secondary prevention of sudden cardiac death due to life-threatening ventricular tachyarrhythmias include: • Previous ventricular tachyarrhythmias • Acute coronary disease • Left ventricular dysfunction • Cardiomyopathy • Inherited primary arrhythmia syndromes • Congenital heart disease • Inflammatory, rheumatic and valvular heart disease
- Product owner address
- 710 Medtronic Parkway, Minneapolis, MN 55432, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.