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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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2400579ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400579ĐKLH/BYT-HTTB
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Device Details

Signal transmission for the heart rhythm generator and the heart defibrillator
VN: Dây dẫn tín hiệu cho máy tạo nhịp tim và máy phá rung tim
Risk Class TTBYT Loại D

Registration Details

2400579ĐKLH/BYT-HTTB

17001284/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Biotronik SE & Co. KG

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