Occlutech

Main information

  • Trade name:
  • Occlutech PDA Occluder - Cardiac occluder
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Occlutech PDA Occluder - Cardiac occluder
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219253
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219253

Getz Healthcare Pty Ltd - Occlutech PDA Occluder - Cardiac occluder

ARTG entry for

Medical Device Included Class III

Sponsor

Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

15/01/2014

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

Occlutech Tibbi Urunler San Ve Tic Ltd Sti

AHL Serbest Bolgesi E-5 Blok

Bakirkoy, Istanbul, 34149

Turkey

Products

1. Occlutech PDA Occluder - Cardiac occluder

Product Type

Single Device Product

Effective date

15/01/2014

GMDN

45418 Cardiac occluder

Functional description

The occluder and supplied pusher are connected by a threaded coupling and loaded via an appropriate

loader into an introducing sheath, which has previously been positioned over a guidewire into the

descending aorta. The PDA occluder and connected pusher are advanced through to the tip of the

introducing sheath and slowly released. Once the position of the implant is confirmed by multiple

angiograms, the introducing sheath is retracted so the shank of the implant unfolds inside the PDA.

Intended purpose

The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a

catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus

(PDA).

Variant information

Diameter (mm) D1 9 - 24

Shape long shank

Diameter (mm) D3 5 - 18

Length (mm) 4.25 - 16

Shape standard

Diameter (mm) D2 3.5 - 14

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 08:06:11 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