Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Valvulotome
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIa
- 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.
LeMaitre Vascular Inc
63 2nd Avenue
Burlington, Massachusetts, 01803
United States Of America
Single Device Product
The valvulotome is a self sizing, self centering blade for well positioned, clean valve ablation in veins. The
device is used in popliteal, tibial and peroneal veins for the removal of incompetent valves. The device is
used for in situ vein bypass.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:44:05 AEDT
This is not an ARTG Certificate document.
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