Despite closing the interventricular septal defect - Vietnam Registration 2403510ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Despite closing the interventricular septal defect 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 2403510ĐKLH/BYT-HTTB and manufactured by Shanghai Shape Memory Alloy Co.,Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ THÁI VÂN PHONG.
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Device Details
Registration Details
2403510ĐKLH/BYT-HTTB
000.00.04.G18-240721-0001
Theo theo phụ lục
Theo phụ lục
Technical Details
The plug to close the pericardial tunnel communication defect is intended to be used to close the pericardial tunnel communication defect by the minimally invasive catheter. The plug to close the pericardial tunnel defect of the myocardium is indicated for patients with complex ventricular septal defect (VSD) who have a significant defect size requiring closure (large left-to-right shunt volume, increased pulmonary pressure and/or clinical symptoms of congestive heart failure), and who are considered to be at high risk for surgical closure of the defect by trans-catheter atrial or aortic valve surgery, based on their anatomical status and/or overall medical condition.
Dates and Status
Nov 14, 2024