Zephyr

Main information

  • Trade name:
  • Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216415
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216415

MD Solutions Australasia Pty Ltd - Zephyr Penile Implant - Prosthesis, internal, penile, inflatable

ARTG entry for

Medical Device Included Class IIb

Sponsor

MD Solutions Australasia Pty Ltd

Postal Address

Unit 1/16-18 Tennyson Street,WILLIAMSTOWN NORTH, VIC, 3016

Australia

ARTG Start Date

23/10/2013

Product category

Medical Device Class IIb

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

Zephyr Surgical Implants

Rue du Conseil-General 14

Geneve, , CH-1205

Switzerland

Products

1. Zephyr Penile Implant - Prosthesis, internal, penile, inflatable

Product Type

Medical device system

Effective date

23/10/2013

GMDN

36250 Prosthesis, internal, penile, inflatable

Intended purpose

The penile implant is a prosthesis that produces erections. This hydraulic implant comprises two inflatable

cylinders (hollow implants), which are implanted in the penis. They are connected to a reservoir, implanted

in the pelvis, and a manual pump implanted in the scrotum. This implant is mostly manufactured from

silicone. The hollow implants are filled under pressure to trigger penile rigidity.

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 05:09:33 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