Generator

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

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Public Summary

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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.

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