Pure Global AI
HSA · registration DE0510092

Medtronic Micra™ VR2 Single Chamber Transcatheter Pacing System

SingaporeCardiovascularClass DMedtronic, Inc
Official record identity
Registration number
DE0510092
Model name
Micra™ VR2; Micra™ Introducer
Model identifier
MC2VR01; MI2355A
Registration date
November 29, 2024
Source update date
July 30, 2025
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
Published parties
Product owner
Medtronic, Inc
Official description

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.

Additional source fields
Product owner address
710 Medtronic Parkway, Minneapolis, MN 55432, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

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.