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Permanent pacemaker with the function of resynchronizing the heart and eliminating arrhythmia, compatible with MRI - Vietnam Registration 2402316ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Permanent pacemaker with the function of resynchronizing the heart and eliminating arrhythmia, compatible with MRI in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2402316ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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2402316ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402316ĐKLH/BYT-HTTB
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Device Details

Permanent pacemaker with the function of resynchronizing the heart and eliminating arrhythmia, compatible with MRI
VN: Máy tạo nhịp vĩnh viễn có chức năng tái đồng bộ tim và phá rung, tương thích MRI
Risk Class TTBYT Loại D

Registration Details

2402316ĐKLH/BYT-HTTB

000.00.04.G18-210428-0005

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Medtronic Plc

Technical Details

The cardiac resynchronization therapy defibrillator, designed to be implanted into the body and used for an extended period, is intended to monitor and regulate the heart rate of the patient. The device will sense the intrinsic electrical activity through the electrodes on the lead and analyze the sensed activity based on the programmed detection criteria. The device will perform pacing therapies to treat heart failure and bradycardia, and perform anti-tachycardia pacing, cardioversion, and anti-arrhythmic therapies to treat life-threatening rapid arrhythmias.

Dates and Status

Aug 30, 2024