Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, active
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
02-12-2017
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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIb
Manufactured by:
Synapse Biomedical Inc 300 Artino Street, Oberlin, OH, 44074 United States Of America
Therapeutic area:
47810 - Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, active
Therapeutic indications:
The PermaLoc Electrode is an implantable component of Synapse Biomedical's NeuRx Diaphragm Pacing System and is intended to conduct electrical current from the NueRx RA/4 External Pulse Generator to the phrenic nerve motor point in the diaphragm, to contract the diaphragm muscles.
Authorization status:
A
Authorization date:
2009-01-20
