OMNI II Programmer (with OMNI Smart Software) System Kit - Cardiac contractility modulation system programmer

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)
02-11-2017

可用日期:

Impulse Dynamics (Australia) Pty Ltd

类:

Class III

厂商:

Impulse Dynamics (USA) Inc 50 Lake Center Suite 100, Marlton, NJ, 08053 United States Of America

治疗领域:

47467 - Cardiac contractility modulation system programmer

疗效迹象:

The kit consists of a lap top (equipped with the required software), programmer wand, interface box and cabling for interrogating & programming the OPTIMIZER SMART IPG. The wand is placed directly over the implant site where it communicates via telemetry with the implanted IPG. In conjunction with the OPTIMIZER SMART IPG the programmer can log IPG activity, store, upload & download such log files to/from a remote, dedicated server, and can reprogram therapy parameters. The OMNI II Programmer (with OMNI Smart Software) System Kit uses the OPTIMIZER SMART programming application software to communicate with the Optimizer SMART IPG via telemetry to record device data. The Optimizer SMART IPG is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy.

授权状态:

A

授权日期:

2017-08-30

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