Vietnam MOH registration 2301022ĐKLH/BYT-HTTB

Wireless Permanent Pacemaker

VN: Máy tạo nhịp vĩnh viễn không dây

Vietnam·Risk Class TTBYT Loại D·Micra AV Leadless Transcatheter Pacing System·Medtronic Ireland·Registered Sep 28, 2023

Registration details

Analysis ID: 2301022ĐKLH/BYT-HTTB
Submission ID: 17000631/ĐKLH-BYT-TB-CT
Product Type: Micra AV Leadless Transcatheter Pacing System
Product Code: MC1AVR1

Company information

Manufacturer: Medtronic Ireland
Manufacturer Country: IRELAND

Technical details

Intended Use: The Micra AV Model MC1AVR1 is indicated to provide ventricular demand pacing (VDD) in patients when the dual-chamber cardiac resynchronization therapy (CRT) via the veins is not feasible or the therapy is ineffective and a transvenous ventricular pacing is contraindicated. The conditions for patients with poor heart rhythm and not using transvenous pacing include, but are not limited to: complex anatomy, need for continued venous access, or high risk of infection. The device provides ventricular demand pacing (VDD) at rest and ventricular rate-responsive pacing (VVIR) during periods of high patient activity. Ventricular demand pacing (VDD) and ventricular rate-responsive pacing (VVIR) via a transvenous lead can vary according to the patient's condition, level of activity, and are limited when the ventricular pacing rate is high. During periods of intermittent ventricular demand pacing (VDD), the device will provide ventricular pacing support with the ability to increase the heart rate. The Micra AV Model MC1AVR1 is indicated for patients who have undergone one of the following: • High-degree AV block (complete heart block) or permanent AV block in the absence of atrial fibrillation (AF) • High-degree AV block (complete heart block) or permanent AV block in the presence of paroxysmal atrial fibrillation (AF) • High-degree AV block (complete heart block) or permanent AV block in the presence of chronic atrial fibrillation (AF) when the restoration of the atrial rhythm is still planned The device is designed to be used in the right ventricle only.

Dates and status

Registration Date: Sep 28, 2023

About this record

Access comprehensive regulatory information for Wireless Permanent 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 2301022ĐKLH/BYT-HTTB and manufactured by Medtronic Ireland.

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