Three-chambered cardiac pacemaker with heart resynchronization function
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Biotronik SE & Co. KG·Registered Aug 27, 2024- Analysis ID
- 2402074ĐKLH/BYT-HTTB
- Submission ID
- 17001299/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Biotronik SE & Co. KG
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Biotronik SE & Co. KG
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- These are the implanted cardiac resynchronization therapy (CRT: HF-T and HF-T QP) and the implanted cardiac resynchronization therapy (CRT-P: HF-T and HF-T QP). The cardiac resynchronization therapy (CRT) device is a part of the implanted cardiac resynchronization therapy system, which includes the CRT device and the signal transmission wires. The main function of the system is first to sense the intrinsic heart rate and second to provide low-energy electrical pacing, as well as to provide low-energy anti-tachycardia pacing when necessary to ensure a stable heart rate or to support the intrinsic heart rate when necessary. The CRT-P systems have all the functions mentioned and in addition provide permanent sensing and pacing of the left ventricle. Implantation of the cardiac resynchronization therapy device is a symptomatic treatment with the following objectives: •Sensing and recording the heart rate and automatically detecting slow and fast heartbeats (PMs and CRT-Ps) •Compensating for slow heart rate through atrial or ventricular or sequential atrioventricular pacing (AV) (PM and CRT-P) •Physiological pacing (LBB(A)P) by stimulating the conduction system (PM and CRT-P) •Terminating fast atrial tachycardia (AT/AF) through anti-tachycardia pacing (ATP) in the atrium (PMs and CRT-Ps) •Cardiac resynchronization through multi-site ventricular pacing or through physiological pacing (CRT-Ps, e.g., biventricular pacing)
- Registration Date
- Aug 27, 2024
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Access comprehensive regulatory information for Three-chambered cardiac pacemaker with heart resynchronization function 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 2402074ĐKLH/BYT-HTTB and manufactured by Biotronik SE & Co. KG. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.
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