Medtronic Micra™ VR2 Single Chamber Transcatheter Pacing System - HSA Registration DE0510092
Access comprehensive regulatory information for Medtronic Micra™ VR2 Single Chamber Transcatheter Pacing System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0510092 and owned by Medtronic, Inc. The device was registered on November 29, 2024.
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.
Micra VR2 Model MC2VR01 is indicated for use in patients who have experienced one or more of the following conditions: • paroxysmal or permanent high-grade AV block in the presence of AF • paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when a dual-chamber transvenous pacing system is considered difficult, high risk, or not deemed necessary for effective therapy • symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when a dual-chamber transvenous pacing system is considered difficult, high risk, or not deemed necessary for effective therapy Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity. The device is designed to be used only in the right ventricle.