ENT cartilage

Main information

  • Trade name:
  • ENT cartilage cutter blade
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ENT cartilage cutter blade
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217454
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217454

Kevin Grundy (IBD) Pty Ltd - ENT cartilage cutter blade

ARTG entry for

Medical Device Included Class IIa

Sponsor

Kevin Grundy (IBD) Pty Ltd

Postal Address

Suite 305 / 185 Elizabeth Street,St James Trust Building,SYDNEY, NSW, 2000

Australia

ARTG Start Date

19/11/2013

Product category

Medical Device Class IIa

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

Grace Medical Inc

8500 Wolf Lake Drive Suite 110

Memphis, Tennessee, 38133

United States Of America

Products

1. ENT cartilage cutter blade

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

60394 ENT cartilage cutter blade

Intended purpose

to be mounted onto an ENT cartilage cutter to cut thin slices of harvested cartilage tissue (e.g.,

tragus-derived autograft) for patient implantation during an ear/nose/throat (ENT) procedure (e.g., middle

ear surgery)

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 02:18:52 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

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FDA - U.S. Food and Drug Administration

15-3-2019


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Europe - EMA - European Medicines Agency

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Europe - EMA - European Medicines Agency

15-3-2019


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Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Hydroxy-propyl-beta-cyclodextrin, Treatment of Niemann-Pick disease, type C, 30/08/2011, Positive

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Europe - EMA - European Medicines Agency

15-3-2019


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Europe - EMA - European Medicines Agency

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Ongentys (Bial - Portela and Ca, SA)

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Europe -DG Health and Food Safety

15-3-2019

NovoMix (Novo Nordisk A/S)

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Europe -DG Health and Food Safety

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Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2071 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002667/T/0007

Europe -DG Health and Food Safety

14-3-2019


Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806

Europe - EMA - European Medicines Agency

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Active substance: Fluoxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2089 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/T/31

Europe -DG Health and Food Safety

14-3-2019


Orphan designation: Treprostinil diethanolamine (oral use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive

Orphan designation: Treprostinil diethanolamine (oral use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive

Orphan designation: Treprostinil diethanolamine (oral use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Treprostinil diethanolamine, Treatment of systemic sclerosis, 15/05/2009, Positive

Orphan designation: Treprostinil diethanolamine, Treatment of systemic sclerosis, 15/05/2009, Positive

Orphan designation: Treprostinil diethanolamine, Treatment of systemic sclerosis, 15/05/2009, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Entolimod, Treatment of acute radiation syndrome, 11/01/2016, Positive

Orphan designation: Entolimod, Treatment of acute radiation syndrome, 11/01/2016, Positive

Orphan designation: Entolimod, Treatment of acute radiation syndrome, 11/01/2016, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804

Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804

Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804

Europe - EMA - European Medicines Agency