Summary for ARTG Entry:
Hologic Australia Pty Ltd - Marker, lesion localization, implantable
ARTG entry for
Medical Device Included Class IIb
Hologic Australia Pty Ltd
PO Box 1971,MACQUARIE CENTRE, NSW, 2113
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.
250 Campus Drive
Marlborough, MA, 01752
United States Of America
1. Marker, lesion localization, implantable
Single Device Product
40808 Marker, lesion localization, implantable
Intended to be implanted to mark tumour/lesions to allow accurate localisation for therapy.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:22:00 AEDT
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