Summary for ARTG Entry:
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
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class III
- 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.
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA, 01752
United States Of America
1. Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary
artery stent, non-biodegradable-polymer-coated
Medical device system
56284 Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
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
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.
Length (mm) 8 - 38
Diameter (mm) 2.25 - 4.00
No Specific Conditions included on Record
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