Pulmonary artery catheter with bio-hybrid valve - Vietnam Registration 2402213ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Pulmonary artery catheter with bio-hybrid valve 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 2402213ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.
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Device Details
Registration Details
2402213ĐKLH/BYT-HTTB
17000724/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
The intended purpose: The intended use of the Contegra valve conduit is to restore blood flow through the heart in patients under 18 years of age who require replacement or reconstruction of the Right Ventricular Outflow Tract (RVOT). Indications: The Contegra valve conduit is indicated for implantation in patients under 18 years of age, who have a need or clinical condition of: • Congenital heart defects requiring connection or reconstruction of the RVOT using a right ventricular to pulmonary artery conduit (e.g., tetralogy of Fallot, common ventricular outflow tract, transposition of the great arteries, double outlet right ventricle, or other non-congenital aortic valve abnormalities) • Replacement of a malfunctioning pulmonary valve prosthesis or a right ventricular to pulmonary artery conduit (RV-PA) that was clinically indicated and required surgical intervention
Dates and Status
Aug 27, 2024