Dilator

Main information

  • Trade name:
  • Dilator, vascular
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Dilator, vascular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217009
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217009

LivaNova Australia Pty Ltd - Dilator, vascular

ARTG entry for

Medical Device Included Class IIa

Sponsor

LivaNova Australia Pty Ltd

Postal Address

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

Australia

ARTG Start Date

7/11/2013

Product category

Medical Device Class IIa

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

Sorin Group USA Inc

14401 West 65th Way

ARVADA, COLORADO, 80004

United States Of America

Products

1. Dilator, vascular

Product Type

Medical device system

Effective date

7/11/2013

GMDN

11268 Dilator, vascular

Intended purpose

The Sorin Vascular Dilator Kit consists of a scalpel, insertion needle, guidewire, and a set of 5 dilators (8,

12, 16, 20, and 24 French). The kit is intended for use in dilating a vessel to aid in introduction of a

catheter or cannula. The kit is packaged sterile and intended for single use.

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 03:38:00 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

5-10-2009

Decision on future reimbursement status for medicinal products in ATC group C04 (peripheral vasodilators)

Decision on future reimbursement status for medicinal products in ATC group C04 (peripheral vasodilators)

On 21 September 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group (peripheral vasodilators).

Danish Medicines Agency

30-6-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C04 (Peripheral vasodilators)

Danish Medicines Agency

There are no news related to this product.