Singapore HSA registration DE0510093

Medtronic Micra™ AV2 Dual Chamber Transcatheter Pacing System

Singapore flagSingapore·CLASS COM·Medtronic, Inc·Registered November 29, 2024
Device classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0510093
Registration Date
November 29, 2024
Retention Due Date
November 28, 2025
Product 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.
Product Owner
Short Name
Medtronic, Inc
Address
710 Medtronic Parkway, Minneapolis, MN 55432, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
Micra™ AV2 Micra™ Introducer
Model Identifier(s)
MC2AVR1 MI2355A
About this record

Access comprehensive regulatory information for Medtronic Micra™ AV2 Dual 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 DE0510093 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.

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