Open Pivot AP360 HV Mitral - Model 505DMxx series - Prosthesis, internal, valve, cardiac, artificial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
09-11-2017

Dostopno od:

Medtronic Australasia Pty Ltd

Razred:

Class III

Izdeluje:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America

Terapevtsko območje:

35590 - Prosthesis, internal, valve, cardiac, artificial

Terapevtske indikacije:

Leaflet movement is controlled by pivot guides located on the inner circumference of the orifice ring. The leaflets move smoothly within these guides. There are no recesses or cavities in the pivot area. The Medtronic Open Pivot Heart Valve can be rotated for optimal positioning once implanted in either the aortic or mitral position. The Medtronic Open Pivot Heart Valve is intended for use as a replacement valve in patients with diseased, damaged, or malfunctioning heart valves. This device may also be used to replace a previously implanted prosthetic heart valve.

Status dovoljenje:

A

Datum dovoljenje:

2014-01-13

Opozorila o iskanju, povezana s tem izdelkom