Generator

Main information

  • Trade name:
  • Generator, lesion, radio frequency
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Generator, lesion, radio frequency
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221479
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221479

Terumo Australia Pty Ltd - Generator, lesion, radio frequency

ARTG entry for

Medical Device Included Class IIb

Sponsor

Terumo Australia Pty Ltd

Postal Address

PO Box 312,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/03/2014

Product category

Medical Device Class IIb

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

Shanghai AngioCare Medical Technology Ltd

590 Ruiqing Road Building 6 Suite 301

East Zhangjiang High-Tech Park, Shanghai,

201201

China

Products

1. Generator, lesion, radio frequency

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

35156 Radio-frequency ablation system generator

Intended purpose

The Iberis Radio Frequency Generator is intended to deliver radio frequency energy for renal denervation

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 12:55:18 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

There are no safety alerts related to this product.

10-10-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/SLxGKzIIgc

FDA - U.S. Food and Drug Administration

24-9-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/z8SW2mlb86

FDA - U.S. Food and Drug Administration