Singapore HSA registration DE0510092
Medtronic Micra™ VR2 Single Chamber Transcatheter Pacing System
Device classification
- Device Class
- CLASS COM
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0510092
- Registration Date
- November 29, 2024
- Retention Due Date
- November 28, 2025
Product 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.
Product Owner
- Name
- Medtronic, Inc
- 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™ VR2 Micra™ Introducer
- Model Identifier(s)
- MC2VR01 MI2355A
About this record
Access comprehensive regulatory information for Medtronic Micra™ VR2 Single 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 DE0510092 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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