Vietnam MOH registration 2402213ĐKLH/BYT-HTTB

Pulmonary artery catheter with bio-hybrid valve

VN: Van tim sinh học kèm ống động mạch phổi

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Medtronic Plc·Registered Aug 27, 2024

Registration details

Analysis ID: 2402213ĐKLH/BYT-HTTB
Submission ID: 17000724/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Medtronic Plc
Manufacturer Country: Theo theo phụ lục
Product Owner: Medtronic Plc
Authorized Representative: CÔNG TY TNHH MEDTRONIC VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Aug 27, 2024

About this record

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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