Cardiac pulse generator analyser cable, single-use
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
07-11-2017
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Available from:
Impulse Dynamics (Australia) Pty Ltd
Class:
Class Is
Manufactured by:
Impulse Dynamics NV Schottegatweg Oost 10 Unit AIK, Curacao, Dutch Caribbean Netherlands
Therapeutic area:
46842 - Cardiac pulse generator analyser cable, single-use
Therapeutic indications:
The sterile lead extension cable connects the implanted leads with a non-sterile test pulse generator (IPG) outside the sterile field and is used during implant and are only used to check Cardiac Contractility Modulation (CCM) system functionality just before the implanted leads are attached to a sterile IPG. The lead extension cable is then discarded.
Authorization status:
A
Authorization date:
2015-02-20
