Summary for ARTG Entry:
Boston Scientific Pty Ltd - SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System -
Drug-eluting coronary artery stent, 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. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery
Medical device system
58771 Drug-eluting coronary artery stent, biodegradable-polymer-coated
The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 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.
The SYNERGY Stent System is indicated for improving coronary luminal diameter in patients with
symptomatic ischemic heart disease, including patients with acute myocardial infarction,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 - 4.0 mm.
Diameter (mm) 2.25 - 4.00
Length (mm) 8 - 38
No Specific Conditions included on Record
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