Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Abbott Vascular Division of Abbott Australasia Pty Ltd - Biodegradable drug-eluting coronary artery stent
ARTG entry for
Medical Device Included (Export Only) Class 1
Abbott Vascular Division of Abbott Australasia Pty Ltd
Locked Bag 2005,North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class 1
- 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.
3200 Lakeside Drive
Santa Clara, CA, 95054
United States Of America
1. Biodegradable drug-eluting coronary artery stent
Single Device Product
56304 Biodegradable drug-eluting coronary artery stent
The Absorb Bioresorbable Vascular Scaffold is a temporary scaffold indicated for improving coronary
luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in
patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion
length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with
reference vessel diameters (RVD) ? 2.5 mm and ? 3.75 mm.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 01:19:34 AEDT
This is not an ARTG Certificate document.
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