VNS Therapy

Main information

  • Trade name:
  • VNS Therapy Aspire HC Pulse Generator Model 105 - Stimulator, electrical, vagus nerve, antiseizure
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • VNS Therapy Aspire HC Pulse Generator Model 105 - Stimulator, electrical, vagus nerve, antiseizure
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219586
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219586

LivaNova Australia Pty Ltd - VNS Therapy Aspire HC Pulse Generator Model 105 - Stimulator, electrical,

vagus nerve, antiseizure

ARTG entry for

Medical Device Included AIMD

Sponsor

LivaNova Australia Pty Ltd

Postal Address

16 - 18 Hydrive Close,South Dandenong, VIC, 3175

Australia

ARTG Start Date

24/01/2014

Product category

Medical Device AIMD

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

Cyberonics Inc

100 Cyberonics Boulevard

Houston, TX, 77058

United States Of America

Products

1. VNS Therapy Aspire HC Pulse Generator Model 105 - Stimulator, electrical, vagus nerve, antiseizure

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

34210 Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

Functional description

The Pulse Generator is an implantable, multiprogrammable pulse generator that delivers electrical signals

to the vagus nerve. The Pulse Generator is housed in a hermetically sealed titanium case and is powered

by a single battery. Electrical signals are transmitted from the Pulse Generator to the vagus nerve by the

Lead. The Lead and the Pulse Generator make up the implantable portion of the VNS Therapy System.

Intended purpose

The Vagus Nerve Stimulation Therapy System is indicated for the treatment of chronic or recurrent

depression in patients that are in a

treatment-resistant or treatment-intolerant major depressive episode and for use as an adjunctive therapy

in reducing the frequency of

seizures in patients whose epileptic disorder is dominated by partial seizures or generalized seizures that

are refractory to antiepileptic

medications.

Variant information

Nil variant (as 1 device) 0

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 10.11.2017 at 07:06:41 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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Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

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Europe - EMA - European Medicines Agency

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Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

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Europe - EMA - European Medicines Agency

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Europe - EMA - European Medicines Agency

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Europe - EMA - European Medicines Agency

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Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells

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Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

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Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells

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Europe - EMA - European Medicines Agency

12-12-2018


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Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin

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Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

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Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live attenuated Listeria monocytogenes transfected with plasmids encoding HPV fusion protein

Scientific recommendation on classification of advanced therapy medicinal products: Live attenuated Listeria monocytogenes transfected with plasmids encoding HPV fusion protein

Scientific recommendation on classification of advanced therapy medicinal products: Live attenuated Listeria monocytogenes transfected with plasmids encoding HPV fusion protein

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Collagenase enzyme from Clostridium histolyticum

Scientific recommendation on classification of advanced therapy medicinal products: Collagenase enzyme from Clostridium histolyticum

Scientific recommendation on classification of advanced therapy medicinal products: Collagenase enzyme from Clostridium histolyticum

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

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Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency