Summary for ARTG Entry:
Boston Scientific Pty Ltd - Epidural space locator
ARTG entry for
Medical Device Included Class IIa
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class IIa
- 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 Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, CA, 91355
United States Of America
1. Epidural space locator
Single Device Product
58220 Epidural space locator
This device is intended to be used prior to introducing paddle leads into the epidural space. It is designed
to help verify that the epidural space is cleared for placement of the paddle lead.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:31:37 AEDT
This is not an ARTG Certificate document.
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