SelectSecure MRI SureScan 3830 - Lead, pacemaker, implantable, endocardial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
28-05-2019

可用日期:

Medtronic Australasia Pty Ltd

类:

Class III

厂商:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, Minnesota, 55432 United States Of America

治疗领域:

35223 - Lead, pacemaker, implantable, endocardial

疗效迹象:

The device is a steroid eluting, bipolar, transvenous, nonretractable screw-in, atrial/ventricular, catheter delivered lead. It has a nonretractable helical electrode for active fixation in the endocardium by rotating the lead body in a clockwise direction. The lead also has a second, larger ring electrode proximal to the tip electrode and an IS-1 Bipolar (BI) connector. Upon exposure to body fluids, the steroid elutes from the lead tip. The Model 3830 lead is intended for pacing and sensing in the right atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to right ventricular pacing in a single or dual chamber pacing system.

授权状态:

A

授权日期:

2018-03-20

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