Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
01-12-2017

から入手可能:

Biotronik Australia Pty Ltd

クラス:

AIMD

製:

Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany

治療領域:

47265 - Dual-chamber pacemaker, rate-responsive

適応症:

Edora 8 DR-T housing is made of biocompatible titanium, welded from the outside and hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an antipole in the case of unipolar lead configuration. Implantable Cardiac Pulse Generator, Dual Chamber, Rate Adaptive, unipolar/bipolar, IS-1 Compatible, with Home Monitoring. ProMRI? labelled (MR conditional) pacemakers are conditionally safe for use in the MRI environment. Edora is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: ?Compensation of bradycardia by atrial, ventricular, or AV sequential pacing

認証ステータス:

A

承認日:

2017-06-22

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