OTO SR Pacemaker - Single-chamber pacemaker, rate-responsive

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
10-02-2020

제공처:

Microport Crm Pty Ltd

수업:

AIMD

Manufactured by:

MicroPort CRM S.r.l Via Crescentino sn, Saluggia, VC, 13040 Italy

치료 영역:

47267 - Single-chamber pacemaker, rate-responsive

치료 징후:

OTO SR Pacemaker is single-chamber rate responsive pacemaker. It is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity OTO SR Pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some forms of symptomatic tachyarrhythmias; vasovagal syndromes or hypersensitive carotid sinus syndromes. Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. The device(s) are MR Conditional in the 1.5T and 3T MR environment.

승인 상태:

A

승인 날짜:

2019-12-16

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