Summary for ARTG Entry:
Advanced Biomedical Pty Ltd - CardiaMed Aortic Supra-annular Prosthetic Heart Valve (ADM.XX-1Su) -
Prosthesis, internal, valve, cardiac, artificial
ARTG entry for
Medical Device Included Class III
Advanced Biomedical Pty Ltd
PO Box 222,RINGWOOD EAST, VIC, 3135
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.
Mandenmakerstraat 15B BJ Uden
, , 5405
1. CardiaMed Aortic Supra-annular Prosthetic Heart Valve (ADM.XX-1Su) - Prosthesis, internal, valve, cardiac,
Single Device Product
35590 Prosthesis, internal, valve, cardiac, artificial
The aortic mech heart valve has an occluder made of two leaflets that pivot from open position to
closed.The valve has a sewing cuff for supra-annular position of implantation.The valve housing is
reinforced with a titanium stiffening ring.The leaflets rotate around the central axis of the valve housing
without restricting blood flow and eliminate stagnation.The leaflets are aerodynamic and create smoothly
spreading blood flow,preventing blood turbulence,speeding valve closure and opening.
Aortic prosthetic heart valve is intended for replacement of the diseased aortic human heart valve.
Diameter (mm) 17-23mm
No Specific Conditions included on Record
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