Medtronic Micra™ VR2 Single Chamber Transcatheter Pacing System
- Registration number
- DE0510092
- Model name
- Micra™ VR2; Micra™ Introducer
- Model identifier
- MC2VR01; MI2355A
- Registration date
- November 29, 2024
- Source update date
- July 30, 2025
- Risk class
- Class D
- Product owner
- Medtronic, Inc
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
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.
- Product owner address
- 710 Medtronic Parkway, Minneapolis, MN 55432, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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