Biliary
Main information
- Trade name:
- Biliary catheter guidewire, single-use
- Available from:
- Boston Scientific Pty Ltd
- Class:
- Class IIa
- 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:
- 218955
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
218955
Boston Scientific Pty Ltd - Biliary catheter guidewire, single-use
ARTG entry for
Medical Device Included Class IIa
Sponsor
Boston Scientific Pty Ltd
Postal Address
PO Box 332,BOTANY, NSW, 1455
Australia
ARTG Start Date
6/01/2014
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
NeoMetrics Inc
2605 Fernbrook Lane Suite J
Plymouth, MN, 55447
United States Of America
Products
1. Biliary catheter guidewire, single-use
Product Type
Procedure Pack
Effective date
6/01/2014
GMDN
46749 Biliary catheter guidewire, single-use
Intended purpose
Guidewire intended for use in selective cannulation of the biliary ducts including the common bile,
pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic
devices during endoscopic procedures.
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 08:56:24 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
8-5-2018
Orphan designation: Ivosidenib, for the: Treatment of biliary tract cancer
Europe - EMA - European Medicines Agency
13-9-2018
European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018
This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...
Europe - EMA - European Medicines Agency