Signal transmission for the heart rhythm generator and the heart defibrillator - Vietnam Registration 2400579ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Signal transmission for the heart rhythm generator and the heart defibrillator 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 2400579ĐKLH/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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Device Details
Registration Details
2400579ĐKLH/BYT-HTTB
17001284/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
The signal-carrying wire, together with the pacemaker or cardioversion pacemaker (ICD) compatible, forms a device system for: • dual or single lead sensing of the heart rate/heart's intrinsic frequency and • dual or single lead pacing of the right atrium (Solia S and J-shaped Solia) and/or right ventricle (Solia S and T-shaped Solia) by electrical impulses to ensure a stable heart rate or to support the heart's intrinsic rhythm. The signal-carrying wire is implanted into the right atrium (Solia S and J-shaped Solia) or right ventricle (Solia S and T-shaped Solia) of the heart through the venous route. The primary function of the signal-carrying wire as part of the device system is to transmit the signals sensed from the heart to the operating device and to transmit the electrical impulses generated by the pacemaker or ICD to the heart. The signal-carrying wire does not have any additional functions. To reduce the risk of increased pacing threshold, a steroid-coated tip is placed at the end of the signal-carrying wire, which reduces the incidence of atrial inflammation and subsequent fibrosis after implantation.
Dates and Status
May 08, 2024

