Three-chambered cardiac pacemaker with heart resynchronization function
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Biotronik SE & Co. KG·Registered Oct 22, 2024- Analysis ID
- 2402826ĐKLH/BYT-HTTB
- Submission ID
- 17001263/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
- Implantable cardiac rhythm devices are a part of the implantable system, which includes a cardiac rhythm device and various types of electrodes to create the desired heart rhythm. The function of this system includes: the ability to sense the heart's intrinsic rhythm and to pace the heart with low-energy electrical impulses when necessary to ensure a stable heart rhythm or to support the intrinsic heart rhythm when needed. Implantation of a three-chamber cardiac rhythm device is a symptomatic treatment option with the following objectives: • Monitoring heart rhythm and automatically detecting slow heart rhythms • Compensating for slow heart rhythms through the process of atrial pacing, ventricular pacing, or sequential atrial-ventricular pacing • Re-synchronizing the heart through multi-site ventricular pacing.
- Registration Date
- Oct 22, 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 2402826ĐKLH/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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