Summary for ARTG Entry:
Boston Scientific Pty Ltd - CoverEdge 4x8 Surgical Lead - Electrode/lead, stimulator, implantable,
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 Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, CA, 91355
United States Of America
1. CoverEdge 4x8 Surgical Lead - Electrode/lead, stimulator, implantable, neurological
Single Device Product
44040 Neural-tissue electrical stimulation lead
The distal end of the lead has 4 columns of 8 electrodes. On the proximal side, the lead has 4 tails. The
end of each tail has 8 evenly spaced contacts. Each tail of the paddle lead is identified with marker bands.
Each tail corresponds to the respective column of contacts on the paddle. Each tail can be inserted into an
IPG to deliver electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord resulting
in an inhibition of pain sensation.
The surgical paddle leads function as a component of the Precision Spectra™ Spinal Cord Stimulation
systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord,
resulting in an inhibition of pain sensation. The 4x8 Surgical Lead is intended for use with the Precision
Spectra System only.
Width (mm) 9mm and 10mm
No Specific Conditions included on Record
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