VNS Therapy PerenniaDURA Model 303 Lead (303.2 and 303.3) - Electrode/lead, stimulator, implantable, vagus nerve

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
13-11-2017

Dostopno od:

LivaNova Australia Pty Ltd

Razred:

Class III

Izdeluje:

LivaNova USA Inc 100 Cyberonics Blvd, Houston, TX, 77058 United States Of America

Terapevtsko območje:

44041 - Electrode/lead, stimulator, implantable, vagus nerve

Terapevtske indikacije:

The Lead is bifurcated at 1 end and has a single connector pin at the other - compatible with single-receptacle Generators. The Lead insulated with silicone, delivers an electrical signal from the Generator to the vagus nerve. Available in two sizes (2.0 and 3.0 mm electrode diameter) to ensure optimal electrode fit on the nerve. The Lead has 2 helical electrodes and an anchor tether, which coil around the left vagus nerve. The connector end is tunnelled subcutaneously to the Generator pocket. Model 303 Lead - Silicone insulated implantable patient lead, delivering the electrical signal from the Pulse? (Model 102) or DemiPulse? (Model 103) Generators to the vagus nerve. The lead has at one end, two helical electrodes and an anchor tether, which are coiled around the vagus nerve. The opposite end of the lead has a single connector, which is tunneled subcutaneously from the vagus nerve and inserted into the generator. The lead is available in multiple sizes to accommodate different nerve sizes.

Status dovoljenje:

A

Datum dovoljenje:

2011-11-14

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