INGEVITY MRI pace/sense lead passive fixation preformed Atrial J system - Lead, pacemaker, implantable, endocardial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Boston Scientific Pty Ltd

Class:

Class III

Manufactured by:

Cardiac Pacemakers Inc (A wholly owned subs of Guidant Corp A wholly owned subs of Boston Scientific Corp) 4100 Hamline Avenue North, St Paul, Minnesota, 55112-5798 United States Of America

Therapeutic area:

35223 - Lead, pacemaker, implantable, endocardial

Therapeutic indications:

Endocardial pace/sense lead?intended for chronic bipolar pacing and sensing in the atrium and/or ventricle. Leads have a IS-1 bipolar to be used in conjunction with a compatible cardiac device. Leads are MR Conditional when connected to Boston Scientific MR Conditional pulse generators. Steroid-eluting?upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode. Intended for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator

Authorization status:

A

Authorization date:

2015-11-18