Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - CPS Aim, MediGuide Enabled Slittable Inner Catheter (Cannulator) -
Catheter, cardiac, ventricular
ARTG entry for
Medical Device Included Class III
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
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.
St Jude Medical Cardiac Rhythm Management
15900 Valley View Court
Sylmar, California, 91342
United States Of America
1. CPS Aim, MediGuide Enabled Slittable Inner Catheter (Cannulator) - Catheter, cardiac, ventricular
Single Device Product
17613 Catheter, cardiac, ventricular
The device contains a magnetic sensor allowing it to be tracked using the MediGuide system. The catheter
facilitates cannulation to the coronary sinus during surgical implantation procedures. When used in
conjunction with outer guide catheters, the catheter can function as a dual-catheter assembly. It may also
be used for the delivery of contrast medium and St Jude Medical devices, including guidewires. The
package includes 1 inner catheter and 2 valve bypass tools.
For intracardiac access of the coronary sinus, and to serve as a conduit during implantation for the delivery
of contrast medium and St Jude Medical devices, including guidewires. In addition, this catheter can work
with outer guide catheters as a system. This catheter is used with MediGuide System to enable real-time
tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy.
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:17:33 AEDT
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