Vietnam MOH registration 2402754ĐKLH/BYT-HTTB

The pacemaker has the function of resynchronizing the heart and is compatible with MRI

VN: Máy tạo nhịp có chức năng tái đồng bộ tim, tương thích MRI

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Medtronic Plc·Registered Oct 02, 2024

Registration details

Analysis ID: 2402754ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210603-0004
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 cardiac resynchronization therapy defibrillator (CRT-D) is a surgically implanted device designed to be used for an extended period of time to monitor and regulate the heart rhythm of the patient. These devices receive the intrinsic electrical activity through the cardiac leads' electrodes, analyze the heart rhythm based on the programmed sensing parameters, and perform resynchronization therapies to treat the condition of chronic heart failure and heart block. Indications The Solara Quad CRT-P MRI SureScan Model W4TR06/ Solara CRT-P MRI SureScan Model W1TR06 system is indicated for use in patients with heart failure and one or more of the following conditions: • Abnormality of the heart's electrical conduction with a prolonged QRS interval • Reduced ejection fraction (EF), regardless of the degree, as defined by the New York Heart Association (NYHA), and who are indicated for ventricular resynchronization and have a high degree of atrioventricular (AV) block • Reduced EF and who have all of the following: – A history of having a conventional pacemaker or ICD implanted previously – A worsening of heart failure despite optimal medical therapy – A high rate of RV resynchronization Frequency-adaptive resynchronization therapy is performed in patients who may benefit from the increased frequency response capability when increased exercise is performed The atrial and dual-chamber monitoring modes are indicated for patients who may benefit from maintaining AV synchrony.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for The pacemaker has the function of resynchronizing the heart and is compatible with MRI 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 2402754ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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