Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - Generator, lesion, radio frequency
ARTG entry for
Medical Device Included Class IIb
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
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.
St Jude Medical
One St Jude Medical Drive
St Paul, Minnesota, 55117-9913
United States Of America
1. Generator, lesion, radio frequency
Single Device Product
35156 Radio-frequency ablation system generator
The Radio Frequency (RF) generator is intended for use with an EP ablation catheter in creating
endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:46:11 AEDT
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