Driver

Main information

  • Trade name:
  • Driver,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Driver,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216578
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216578

Dentsply IH Pty Ltd - Driver, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Dentsply IH Pty Ltd

Postal Address

Suite 1/ 53 Grandview Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

25/10/2013

Product category

Medical Device Class 1

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

Zest Anchors LLC

2875 Loker Avenue East

Carlsbad, CA, 92010

United States Of America

Products

1. Driver, <specify>

Product Type

Single Device Product

Effective date

25/10/2013

GMDN

16868 Driver, <specify>

Intended purpose

A driver is used to place an abutment onto an implant during a dental surgical procedure.

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 04:49:38 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

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

3-7-2018

DKMA Update June 2018

DKMA Update June 2018

In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

Danish Medicines Agency

17-8-2018

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System.  https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

FDA - U.S. Food and Drug Administration