Vietnam MOH registration 2402082ĐKLH/BYT-HTTB
Unicam monopolar anti-tachycardia pacing device
VN: Máy tạo nhịp có phá rung tim 1 buồng
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Abbott Medical·Registered Aug 27, 2024Registration details
- Analysis ID
- 2402082ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-221221-0017
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Abbott Medical
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Abbott Medical
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI VÀ DỊCH VỤ Y TẾ DMEC
Technical details
- Intended Use
- - Designed to be used with compatible leads to detect and treat life-threatening rapid heart rhythms by providing ventricular pacing and cardioversion. In addition, these devices can detect and treat symptomatic chronic bradycardia by providing sensing and pacing in the right ventricle, and different conduction abnormalities of the atrioventricular node by providing sensing and pacing in the right ventricle and/or right atrium. - ICD devices are indicated for patients who have survived a cardiac arrest or are at high risk of sudden death due to ventricular tachycardia (VT) or ventricular fibrillation (VF). The most common type of implanted device is in the chest area.
Dates and status
- Registration Date
- Aug 27, 2024
About this record
Access comprehensive regulatory information for Unicam monopolar anti-tachycardia pacing 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 2402082ĐKLH/BYT-HTTB and manufactured by Abbott Medical. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI VÀ DỊCH VỤ Y TẾ DMEC.
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