Biliary

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

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Public Summary

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This is not an ARTG Certificate document.

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