Summary for ARTG Entry:
Boston Scientific Pty Ltd - Pacing lead suture sleeve
ARTG entry for
Medical Device Included Class IIb
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class IIb
- 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.
3816 De Soto Boulevard
PALM HARBOR, Florida, 34683
United States Of America
1. Pacing lead suture sleeve
Single Device Product
46225 Pacing lead suture sleeve
A silicone tube that is placed over the lead to protect the lead body insulation from being cut during fixation
of the lead with surgical suture.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:20:46 AEDT
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