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HSA · registration DE0510093

Medtronic Micra™ AV2 Dual Chamber Transcatheter Pacing System

SingaporeCardiovascularClass DMedtronic, Inc
Official record identity
Registration number
DE0510093
Model name
Micra™ AV2; Micra™ Introducer
Model identifier
MC2AVR1; 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

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.

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.