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:
  • 217858
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217858

St Jude Medical Australia Pty Ltd - Generator, lesion, radio frequency

ARTG entry for

Medical Device Included Class IIb

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

29/11/2013

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

St Jude Medical

One St Jude Medical Drive

St Paul, Minnesota, 55117-9913

United States Of America

Products

1. Generator, lesion, radio frequency

Product Type

Single Device Product

Effective date

29/11/2013

GMDN

35156 Radio-frequency ablation system generator

Intended purpose

The Radio Frequency (RF) generator is intended for use with an EP ablation catheter in creating

endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias.

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 12:46:11 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