Medtronic Micra™ AV2 Dual Chamber Transcatheter Pacing System
- Registration number
- DE0510093
- Model name
- Micra™ AV2; Micra™ Introducer
- Model identifier
- MC2AVR1; 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)
Indicated for VDD pacing in patients when a dual chamber transvenous pacing system is considered a poor option or not deemed necessary for effective therapy, and when a right ventricular transcatheter pacing system promoting AV synchrony at rest is acceptable. Conditions when a patient is considered a poor candidate for transvenous pacing may include, but are not limited to, tortuous anatomy, a need to preserve venous access, or increased risk of infection. The device provides AV synchrony at rest and rate responsive (VVIR) pacing during periods of high patient activity. Indicated for use in patients who have experienced one of the following: Paroxysmal or permanent high-grade AV block in the absence of AF, in the presence of paroxysmal AF, in the presence of persistent AF when attempts at restoring sinus rhythm are still planned. 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
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.