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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Johnson & Johnson Medical Pty Ltd

Class:

Class III

Manufactured by:

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

Therapeutic area:

47986 - Female stress urinary incontinence surgical mesh

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2020-12-11