Promus

Main information

  • Trade name:
  • Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradabl
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradabl
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220360
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220360

Boston Scientific Pty Ltd - Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent

System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

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

21/02/2014

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. Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary

artery stent, non-biodegradable-polymer-coated

Product Type

Medical device system

Effective date

21/02/2014

GMDN

56284 Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Functional description

The Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent is mounted on a balloon

expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site

of the lesion. The balloon is then inflated to expand the stent to the appropriate diameter. Finally, the

balloon is deflated and the balloon catheter removed, leaving the stent in

position.

Intended purpose

The Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for

improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including

patients with acute myocardial infarction and patients with concomitant

diabetes mellitus, due to discrete de novo native coronary artery lesions. The treated lesion length should

be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm,28 mm, 32 mm and 38 mm)

with a reference vessel diameter of 2.25 mm - 4.00 mm.

Variant information

Length (mm) 8 - 38

Diameter (mm) 2.25 - 4.00

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 04:23:26 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