Vascular

Main information

  • Trade name:
  • Vascular graft tunneller
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Vascular graft tunneller
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222624
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222624

St Jude Medical Australia Pty Ltd - Vascular graft tunneller

ARTG entry for

Medical Device Included Class 1

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

17/04/2014

Product category

Medical Device Class 1

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

Thoratec Corporation

6035 Stoneridge Drive

Pleasanton, CA, 94588

United States Of America

Products

1. Vascular graft tunneller

Product Type

Single Device Product

Effective date

17/04/2014

GMDN

35950 Vascular graft tunneller

Intended purpose

Provides blunt dissection for the percutaneous lead during pump implantation. It is supplied non-sterile and

may be re-used/re-sterilized.

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 09.11.2017 at 08:48:57 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

22-6-2018

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA - U.S. Food and Drug Administration

19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.

FDA - U.S. Food and Drug Administration

18-5-2018

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use

There is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient's bloodstream, and this or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

25-4-2013

Danish Pharmacovigilance Update, 21 February 2013

Danish Pharmacovigilance Update, 21 February 2013

In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).

Danish Medicines Agency

14-6-2010

Change of the reimbursement for certain cardiovascular products as of 15 November 2010

Change of the reimbursement for certain cardiovascular products as of 15 November 2010

The Reimbursement Committee and the Danish Medicines Agency have reviewed some of the medicinal products used for the treatment of cardiovascular disease (antihypertensives) in order to assess whether they meet the criteria for public reimbursement. The medicinal products concerned are the so-called angiotensin II antagonists and renin inhibitors.

Danish Medicines Agency

9-6-2009

Changes in reimbursement for cardiovascular medicine as of 13 July 2009

Changes in reimbursement for cardiovascular medicine as of 13 July 2009

The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of cardiovascular disease (‘antihypertensives’) in order to assess whether they meet the

Danish Medicines Agency

2-2-2009

Consultation responses on the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09

Consultation responses on the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09

The Danish Medicines Agency's assessment of the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09 for the treatment of cardiovascular diseases has been submitted for consultation with 11 December 2008 as the consultation deadline.

Danish Medicines Agency

21-11-2008

Consultation responses on the future reimbursement status of medicinal products for cardiovascular diseases

Consultation responses on the future reimbursement status of medicinal products for cardiovascular diseases

The Reimbursement Committee’s additional recommendation concerning the future reimbursement status of medicinal products for cardiovascular diseases in ATC groups C02, C03, C07, C08 and C09 (antihypertensives) was submitted for consultation with 19 September 2008 as the consultation deadline

Danish Medicines Agency

29-10-2008

Reassessment of reimbursement status for medicinal products in ATC group C08CA

Reassessment of reimbursement status for medicinal products in ATC group C08CA

The Danish Medicines Agency has assessed the question of the future reimbursement status for medicinal products in ATC group C08CA (dihydropyridine calcium channel blockers) which are used for the treatment of cardiovascular diseases.

Danish Medicines Agency

8-9-2008

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

The Danish Medicines Agency has asked the Reimbursement Committee to reassess the reimbursement status of medicinal products authorised for marketing in Denmark in the ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

7-7-2008

Consultation responses to the recommendation about the reimbursement status for medicinal products for the treatment cardiovascular diseases

Consultation responses to the recommendation about the reimbursement status for medicinal products for the treatment cardiovascular diseases

The Reimbursement Committee's recommendation about the future reimbursement status of medicinal products for the treatment of cardiovascular diseases in ATC groups C02, C03, C07, C08 and C09 (antihypertensive drugs) was submitted for consultation on 5 May 2008.

Danish Medicines Agency

14-2-2008

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Following a request from the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status for medicinal products authorised for marketing in Denmark in ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

24-4-2006

Reassessment of subgroups in ATC group C

Reassessment of subgroups in ATC group C

The Danish Medicines Agency is just beginning to reassess the subgroups in ATC group C, medicinal products for the cardiovascular system, and for the first three months of 2006 the agency expects to be working with the following six subgroups.

Danish Medicines Agency

22-6-2018

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients  https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

FDA - U.S. Food and Drug Administration