Signal transmission for the heart rhythm generator and the heart defibrillator
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Biotronik SE & Co. KG·Registered May 08, 2024- Analysis ID
- 2400579ĐKLH/BYT-HTTB
- Submission ID
- 17001284/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
- 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.
- Registration Date
- May 08, 2024
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.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.