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:
  • 219486
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219486

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Dilator, vascular

ARTG entry for

Medical Device Included Class IIa

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

23/01/2014

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

Navilyst Medical Inc

26 Forest Street

Marlborough, MA, 01752

United States Of America

Products

1. Dilator, vascular

Product Type

Procedure Pack

Effective date

23/01/2014

GMDN

11268 Dilator, vascular

Intended purpose

The device is used for the percutaneous introduction of a guidewire into the vascular system. This kit

contains a Coaxial Sheath/Dilator assembly, 21 G (0.9 mm) vascular introducer needle, and a 0.018 inch

(0.46 mm) floppy tip guidewire.

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 02.12.2017 at 04:37:13 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.