Lacrosse NSE ALPHA Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Nipro Australia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
322823

Public Summary

Summary for ARTG Entry:

322823

Nipro Australia Pty Ltd - Lacrosse NSE ALPHA Coronary Dilatation Catheter - Angioplasty catheter, balloon

dilatation, coronary, basic

ARTG entry for

Medical Device Included Class III

Sponsor

Nipro Australia Pty Ltd

Postal Address

Level 2 / 657 Pacific Highway St Leonards,Sydney, NSW, 2065

Australia

ARTG Start Date

6/09/2019

Product category

Medical Device Class III

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

Goodman Co Ltd

Goodman Research Center 276-1 Idogane-cho

Seto, Aichi, 489-0976

Japan

Products

1. Lacrosse NSE ALPHA Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary,

basic

Product Type

Single Device Product

Effective date

6/09/2019

GMDN

47732 Angioplasty catheter, balloon dilatation, coronary, basic

Functional description

The product is a rapid exchange (RX) semi-compliant balloon catheter with the protruding elements

attached in order to decrease an occurrence of balloon slippage.

This product has a hydrophilic coating applied to the surface.

Intended purpose

The purpose of the use of the product is to dilate atherosclerotic obstructed segments of coronary arteries

that are difficult to dilate by regular POBA (plain old balloon angioplasty) to improve coronary artery flow.

The device is intended to be used in vessels with a reference vessel diameter of 2.00-4.00 mm.

Variant information

Size (mm) 4.00

Size (mm) 3.75

Size (mm) 3.50

Size (mm) 3.25

Size (mm) 3.00

Size (mm) 2.75

Size (mm) 2.50

Size (mm) 2.25

Size (mm) 2.00

Specific Conditions

© 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 02.11.2019 at 04:49:11 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

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