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Dual-chamber Heart Rhythm Generator and Shock Device - Vietnam Registration 2402080ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Dual-chamber Heart Rhythm Generator and Shock Device 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 2402080ĐKLH/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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2402080ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402080ĐKLH/BYT-HTTB
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Device Details

Dual-chamber Heart Rhythm Generator and Shock Device
VN: Máy tạo nhịp tim và phá rung tim hai buồng
Risk Class TTBYT Loại D

Registration Details

2402080ĐKLH/BYT-HTTB

17001293/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Biotronik SE & Co. KG

Technical Details

Rivacor is a type of implantable cardioverter defibrillator (ICD: VR-T, VR-T DX and DR-T) and a type of cardiac resynchronization therapy defibrillator (CRT-Ds: HF-T and HF-T QP). ICD/CRT-D is a component of the implantable system, which includes an ICD/CRT-D and a signal wire. The primary function of the system is to sense and record the intrinsic heart rate and rhythm and, secondarily, to provide low-energy pacing to counteract fast heart rhythms by low-energy shocks or high-energy shocks, as well as low-energy pacing to ensure a stable heart rate or to support the intrinsic heart rhythm. The CRT systems share all the functions mentioned and, in addition, provide the capability of sensing and delivering permanent ventricular pacing. Implantation of an ICD/CRT-D is a symptomatic treatment with the following objectives: • Sensing and recording the heart rate and automatically detecting cardiac arrest (ICD and CRT-D). • Terminating ventricular fibrillation (VF) or rapid ventricular tachycardia (VT) through electrical shock (ICD and CRT-D). • Terminating rapid ventricular tachycardia (VT) through anti-tachycardia pacing (ATP) (ICD and CRT-D). • Compensating for slow heart rates through sequential ventricular or atrioventricular pacing (ICD and CRT-D). • Cardiac resynchronization through multi-site ventricular pacing (CRT-Ds, e.g., biventricular pacing).

Dates and Status

Aug 27, 2024