OptiCross

Main information

  • Trade name:
  • OptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • OptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219096
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219096

Boston Scientific Pty Ltd - OptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound,

diagnostic, intracorporeal, intravascular

ARTG entry for

Medical Device Included Class III

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

10/01/2014

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

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough, MA, 01752

United States Of America

Products

1. OptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal,

intravascular

Product Type

Procedure Pack

Effective date

10/01/2014

GMDN

37895 Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular

Functional description

OptiCross Catheter consists of Imaging Core composed of drive cable with ultrasonic transducer at distal

tip and proximal end of catheter connection to motordrive unit.

Catheter body with distal imaging window lumen & proximal exit at distal end. Proximal shaft lumen with

markers to aid in catheter positioning is attached to telescoping section that has proximal markers for

lesion length assessment.

Intended purpose

This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular

ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional

procedures.

The Catheter is packaged with a Sterile Bag, extension tube, 3 cm3 (cc) and 10 cm3 (cc) syringes and a

4-way stopcock.

Variant information

Nil variant (as 1 device) N/A

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 08:25:57 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