Endotherapeutics Pty Ltd - Prosthesis, internal, incontinence (118082)

ARTG ID 118082

ARTG Name

Endotherapeutics Pty Ltd - Prosthesis, internal, incontinence

Product name

Prosthesis, internal, incontinence

ARTG Date

6 April 2005

Registration Type

Device

Therapeutic good type

Medical device

Manufacturers

Promedon SA

Licence category

INC

Licence status

A

Licence class

Class IIb

Summary

Related information

Prosthesis, internal incontinence (Cancelled from the ARTG under s41GN (1)(b))

11 August 2017

Cancellation or suspension

Regulatory action due to Cancelled by Secretary - As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s41FN(3)(a)., effective 11/08/2017