Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Integra Neurosciences Pty Ltd - Patient monitor, pressure, intracranial
ARTG entry for
Medical Device Included Class IIb
Integra Neurosciences Pty Ltd
Unit 3 / 24-30 Winterton Road, CLAYTON, VIC, 3168
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
- 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.
Integra LifeSciences Production Corporation
11 Cabot Blvd
Mansfield, MA, 02048
United States Of America
1 . Patient monitor, pressure, intracranial
Single Device Product
16763 Patient monitor, pressure, intracranial
ICP monitor intended for use as an interface between compatible strain-gauge type pressure transducers and standard
physiological pressure monitoring systems. Also intended for use as an independent pressure monitor for displaying the mean,
systolic and diastolic values of a physiological pressure waveform in the absence of an external patient monitor.
No Specific Conditions included on Record
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Produced at 22.07.2020 at 09:28:32 AEST
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