CardiaMed

Main information

  • Trade name:
  • CardiaMed Mitral Supra-annular Prosthetic Heart Valve (MDM.XX-1Su) - Prosthesis, internal, valve, cardiac, artificial
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CardiaMed Mitral Supra-annular Prosthetic Heart Valve (MDM.XX-1Su) - Prosthesis, internal, valve, cardiac, artificial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218095
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218095

Advanced Biomedical Pty Ltd - CardiaMed Mitral Supra-annular Prosthetic Heart Valve (MDM.XX-1Su) -

Prosthesis, internal, valve, cardiac, artificial

ARTG entry for

Medical Device Included Class III

Sponsor

Advanced Biomedical Pty Ltd

Postal Address

PO Box 222,RINGWOOD EAST, VIC, 3135

Australia

ARTG Start Date

5/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

CardiaMed BV

Mandenmakerstraat 15B BJ Uden

, , 5405

Netherlands

Products

1. CardiaMed Mitral Supra-annular Prosthetic Heart Valve (MDM.XX-1Su) - Prosthesis, internal, valve, cardiac,

artificial

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

35590 Prosthesis, internal, valve, cardiac, artificial

Functional description

The mitral 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.

Intended purpose

Mitral prosthetic heart valve is intended for replacement of the diseased mitral human heart valve.

Variant information

Diameter (mm) 25-33mm

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 10.11.2017 at 11:52:07 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