Generator
Main information
- Trade name:
- Generator, lesion, radio frequency
- Available from:
- Terumo Australia Pty Ltd
- Class:
- Class IIb
- Medicine domain:
- Humans
- Medicine type:
- Medical device
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
Documents in other languages are available here
- Access to this document is only available to registered users.
Register now for full access
8-11-2018
SQ-RX Model 1010 Pulse Generator – used with Boston Scientific S-ICDs
Hazard alert – potential battery issue
Therapeutic Goods Administration - Australia
15-2-2019
#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall: https://go.usa.gov/xEU
#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall: https://go.usa.gov/xEUhq #MedicalDevice #FDA pic.twitter.com/YNkrpGSOhH
FDA - U.S. Food and Drug Administration
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
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
FDA - U.S. Food and Drug Administration