Medtronic Aurora EV-ICD MRI SureScan™ - HSA Registration DE0510255
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.
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