GYNECARE TVT? ABBREVO? Continence System - Female stress urinary incontinence surgical mesh

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
22-01-2021

Dostopno od:

Johnson & Johnson Medical Pty Ltd

Razred:

Class III

Izdeluje:

Ethicon SARL Puits Godet 20, Neuchatel, CH-2000 Switzerland

Terapevtsko območje:

47986 - Female stress urinary incontinence surgical mesh

Terapevtske indikacije:

Procedural kit:TVT ABBREVO Implant Assembly(Mesh implant & sheath,Polyethylene Tube Receptacles/Helical Passers,Placement Loop with attached Polypropylene Button,Positioning Lines & Atraumatic Winged Guide. Curved HPs preassembled to implant assembly to deliver mesh implant via trans-obturator insideout approach.Atraumatic Winged Guide facilitates passage of HPs thru dissection tract, marked with Insertion Zone-aids surgeon?s assessment of inserted depth. IZ indicates distance 3-4cm from tip WG. GYNECARE TVT? ABBREVO? Continence System is intended for use in women as a sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Status dovoljenje:

A

Datum dovoljenje:

2020-12-11

Opozorila o iskanju, povezana s tem izdelkom