Permanent pacemaker with anti-arrhythmic and MRI-compatible functions
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Medtronic Plc·Registered Aug 27, 2024- Analysis ID
- 2402079ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231211-0018
- 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 purpose of this document: The permanent pacemaker with anti-tachycardia function, compatible with MRI (ICD) is designed to be used for a long time to monitor and regulate the heart rhythm of the patient. The device will sense the intrinsic electrical activity through the electrodes of the lead wire, which is placed in direct contact with the heart. The device will analyze the sensed activity based on the programmed detection parameters. The main function of the device is to provide anti-tachycardia pacing, cardioversion and defibrillation therapies to treat life-threatening rapid heart rhythms. The device also treats bradycardia by pacing therapy. The software is designed to provide information to assist in the decision-making process for selecting diagnostic or therapeutic devices. Indications: The Medtronic device is indicated to automatically treat patients who have, or are at high risk for, life-threatening rapid heart rhythms through the delivery of anti-tachycardia pacing, cardioversion and defibrillation therapies. Conditions that may require the use of an ICD to prevent sudden death from primary or secondary ventricular tachycardia include: • Previous episodes of ventricular tachycardia • Acute coronary syndrome • Left ventricular dysfunction • Cardiomyopathy • Primary genetic arrhythmia syndrome • Congenital heart disease • Rheumatic, arthritic and valvular heart disease Note: For specific patient recommendations, including primary and secondary prevention strategies, consult the current guidelines of the European Society of Cardiology (ESC), the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS).
- Registration Date
- Aug 27, 2024
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Access comprehensive regulatory information for Permanent pacemaker with anti-arrhythmic and MRI-compatible functions 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 2402079ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.
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