Summary for ARTG Entry:
Integra Neurosciences Pty Ltd - Micro-Ventricular Bolt Pressure Monitoring Kit, 110-4HM - Catheter,
ARTG entry for
Medical Device Included Class III
Integra Neurosciences Pty Ltd
Unit 3 / 24-30 Winterton Road,CLAYTON, VIC, 3168
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.
5955 Pacific Center Boulevard
San Diego, CA, 92121
United States Of America
1. Micro-Ventricular Bolt Pressure Monitoring Kit, 110-4HM - Catheter, neurological, ventricular
Medical device system
32585 Catheter, neurological, ventricular
Kit consists of a catheter with a transducer at the distal end that monitors intracranial pressure when
attached to a monitor. Accessory items provide a means to access the cerebral ventricles and secure the
catheter to the skull for simultaneous monitoring and drainage. The kit is used with an external drainage
system supplied separately.
The Camino Micro-Ventricular Bolt Pressure Monitoring Kit is intended to measure intracranial pressure
and access the cerebral ventricles for cerebrospinal drainage.
Nil variant (as 1 device)
No Specific Conditions included on Record
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