Permanent pacemaker with the function of resynchronizing the heart and eliminating arrhythmia, compatible with MRI
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Medtronic Plc·Registered Aug 30, 2024- Analysis ID
- 2402316ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210428-0005
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Medtronic Plc
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Medtronic Plc
- Authorized Representative
- CÔNG TY TNHH MEDTRONIC VIỆT NAM
- Intended Use
- 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.
- Registration Date
- Aug 30, 2024
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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