Summary for ARTG Entry:
LivaNova Australia Pty Ltd - Heart valve prosthesis holder safety clip
ARTG entry for
Medical Device Included Class Is
LivaNova Australia Pty Ltd
16 - 18 Hydrive Close,South Dandenong, VIC, 3175
ARTG Start Date
Medical Device Class Is
- 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.
Sorin Biomedica Cardio SRL
Strada per Crescentino sn
Saluggia, VC, 13040
1. Heart valve prosthesis holder safety clip
Single Device Product
60835 Heart valve prosthesis holder safety clip
A sterile device intended to be attached to a heart valve prosthesis holder during open surgical
implantation of a self-expandable heart valve bioprosthesis, to position, secure, and prevent accidental
release of the heart valve prosthesis holder's holding mechanism (e.g., holding sheath). It is a plastic
attachment with the appropriate size, shape and flexibility. This is a single-use device.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 09.11.2017 at 10:55:54 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information