Vietnam MOH registration 2403634ĐKLH/BYT-HTTB

Reentrant Tachycardia Correcting Pacemaker

VN: Máy tạo nhịp tái đồng bộ tim có phá rung

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Boston Scientific·Registered Nov 19, 2024

Registration details

Analysis ID: 2403634ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220728-0021
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Boston Scientific
Manufacturer Country: Theo theo phụ lục
Product Owner: Boston Scientific
Authorized Representative: CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM

Technical details

Intended Use: The Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-Ds) is indicated for patients at risk for sudden death due to heart arrhythmia and heart failure (including asymptomatic patients with chronic ischemic cardiomyopathy [NYHA class I]).

Dates and status

Registration Date: Nov 19, 2024

About this record

Access comprehensive regulatory information for Reentrant Tachycardia Correcting Pacemaker 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 2403634ĐKLH/BYT-HTTB and manufactured by Boston Scientific. The authorized representative in Vietnam is CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM.

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