Amplitude Australia Pty Ltd - Eclipse BCP Absorbable Interference Screw - Fixation screw, bone, biodegradable (284239)

ARTG ID 284239

ARTG Name

Amplitude Australia Pty Ltd - Eclipse BCP Absorbable Interference Screw - Fixation screw, bone, biodegradable

Product name

Eclipse BCP Absorbable Interference Screw - Fixation screw, bone, biodegradable

ARTG Date

6 January 2017

Registration Type

Device

Therapeutic good type

Medical device

Manufacturers

Biomatlante SA ZA les Quatre Nations

Licence category

INC

Licence status

A

Licence class

Class III

Summary

Related information

Eclipse BCP Absorbable Interference Screw (Suspension from ARTG for a six month period under paragraph 41GA(1)(b) of the Act)

20 December 2017

Cancellation or suspension

Regulatory action due to ARTG 284239 was suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 20/12/2017