Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Nipro Australia Pty Ltd - Lacrosse NSE ALPHA Coronary Dilatation Catheter - Angioplasty catheter, balloon
dilatation, coronary, basic
ARTG entry for
Medical Device Included Class III
Nipro Australia Pty Ltd
Level 2 / 657 Pacific Highway St Leonards,Sydney, NSW, 2065
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.
Goodman Co Ltd
Goodman Research Center 276-1 Idogane-cho
Seto, Aichi, 489-0976
1. Lacrosse NSE ALPHA Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary,
Single Device Product
47732 Angioplasty catheter, balloon dilatation, coronary, basic
The product is a rapid exchange (RX) semi-compliant balloon catheter with the protruding elements
attached in order to decrease an occurrence of balloon slippage.
This product has a hydrophilic coating applied to the surface.
The purpose of the use of the product is to dilate atherosclerotic obstructed segments of coronary arteries
that are difficult to dilate by regular POBA (plain old balloon angioplasty) to improve coronary artery flow.
The device is intended to be used in vessels with a reference vessel diameter of 2.00-4.00 mm.
Size (mm) 4.00
Size (mm) 3.75
Size (mm) 3.50
Size (mm) 3.25
Size (mm) 3.00
Size (mm) 2.75
Size (mm) 2.50
Size (mm) 2.25
Size (mm) 2.00
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Produced at 02.11.2019 at 04:49:11 AEDT
This is not an ARTG Certificate document.
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