E-vita

Main information

  • Trade name:
  • E-vita open plus Stent Graft System - Graft, vascular, synthetic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • E-vita open plus Stent Graft System - Graft, vascular, synthetic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216894
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216894

Device Technologies Australia Pty Ltd - E-vita open plus TAA Stent Graft System - Graft, vascular,

synthetic

ARTG entry for

Medical Device Included Class III

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

4/11/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Jotec GmbH

Lotzenacker 23

, Hechingen, 72379

Germany

Products

1. E-vita open plus Stent Graft System - Graft, vascular, synthetic

Product Type

Medical device system

Effective date

26/08/2014

GMDN

35281 Graft, vascular, synthetic

Functional description

The E-vita open plus delivery system with loaded stentgraft is introduced into the aorta through a median

sternotomy using a guide wire and advanced up to the implantation site.The self-expanding mechanism of

the E-vita open plus stentgraft is triggered by retracting the outer shell of the delivery system.The

stentgraft adapts itself to the shape and size of the sealing zone.

Intended purpose

The E-vita open plus Stent Graft System is indicated for the treatment of aneurysms, dissections and

specific lesions of the thoracic aorta.

Variant information

Diameter (mm) Stent Graft Diameter 20-40

Length (mm) Stent Graft Length 80-240

Width (mm) Collar Width 2-40

Shape With Collar / Without Collar

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 21.11.2017 at 09:31:17 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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