Singapore HSA registration DE0510255
Medtronic Aurora EV-ICD MRI SureScan™
Singapore·CLASS D·Medtronic, Inc·Registered January 17, 2025Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0510255
- Registration Date
- January 17, 2025
- Retention Due Date
- January 16, 2026
Product description
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
- Name
- Medtronic, Inc
- Short Name
- Medtronic, Inc
- Address
- 710 Medtronic Parkway, Minneapolis, MN 55432, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- Auror EV-ICD™ MRI SureScan Epsila EV™ Sternal Tunneling Tool Epsila EV™ Transverse Tunneling Tool Epsila EV™ MRI SureScan™ Lead Epsila EV™ MRI SureScan™ Lead Auror EV-ICD™ MRI SureScan Programmer Software
- Model Identifier(s)
- DVEA3E4 EAZ101 EAZ201 EV240152 EV240163 SW041
About this record
Access comprehensive regulatory information for Medtronic Aurora EV-ICD MRI SureScan™ in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510255 and owned by Medtronic, Inc. The device was registered on January 17, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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