Ovation

Main information

  • Trade name:
  • Ovation Prime Abdominal Stent Graft System - Fill Polymer Kit - Abdominal aortic aneurysm stent
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ovation Prime Abdominal Stent Graft System - Fill Polymer Kit - Abdominal aortic aneurysm stent
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219803
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219803

AA-Med Pty Ltd - Ovation Prime Abdominal Stent Graft System - Fill Polymer Kit - Abdominal aortic

aneurysm stent

ARTG entry for

Medical Device Included Class III

Sponsor

AA-Med Pty Ltd

Postal Address

Level 8 / 1 Chandos Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

3/02/2014

Product category

Medical Device Class III

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

TriVascular Inc

3910 Brickway Boulevard

Santa Rosa, CA, 95403

United States Of America

Products

1. Ovation Prime Abdominal Stent Graft System - Fill Polymer Kit - Abdominal aortic aneurysm stent

Product Type

Medical device system

Effective date

3/02/2014

GMDN

46777 Abdominal aortic aneurysm stent

Functional description

The polymer fills the sealing rings of channels in the wall of the aortic body graft. Prior to use, the two

valves on the fill polymer kit are opened and the fill polymer is mixed. After, the fill syringe is connected to

the fill polymer injection port on the catheter handle. The syringe plunger is then inserted into the

Autoinjector. The Autoinjector applies controlled pressure to inject the fill polymer into the graft.

Intended purpose

Indicated for use in patients diagnosed with an aneurysm in the abdominal aorta having vascular

morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with

vascular access techniques, devices, and/or accessories; Non-aneurysmal proximal aortic neck; adequate

distal iliac landing zone.

Variant information

Nil variant (as 1 device) Nil

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 06:33:22 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

30-9-2018

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FDA - U.S. Food and Drug Administration

29-9-2018

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FDA - U.S. Food and Drug Administration

24-9-2018

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For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

17-9-2018

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

22-7-2018

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22-7-2018

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16-7-2018

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29-6-2018

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#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

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29-6-2018

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

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8-6-2018

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FDA - U.S. Food and Drug Administration

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1-6-2018

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FDA - U.S. Food and Drug Administration

1-6-2018

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FDA - U.S. Food and Drug Administration

30-5-2018

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information  https://go.usa.gov/xQvE9 

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FDA - U.S. Food and Drug Administration

30-5-2018

Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.  https://go.usa.gov/xQvPA  #FDAInnovationChallengepic.twitter.com/wyTkvmptHJ

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FDA - U.S. Food and Drug Administration

30-5-2018

The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018.  #FDAInnovationChallenge

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FDA - U.S. Food and Drug Administration

30-5-2018

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use disorder. #FDA MedicalDevice

FDA - U.S. Food and Drug Administration

30-5-2018

Please click the link for more information on the #FDAInnovationChallenge  https://go.usa.gov/xQvPA 

Please click the link for more information on the #FDAInnovationChallenge https://go.usa.gov/xQvPA 

Please click the link for more information on the #FDAInnovationChallenge https://go.usa.gov/xQvPA 

FDA - U.S. Food and Drug Administration

30-5-2018

As part of FDA’s ongoing effort to address the epidemic of #opioid addiction, the agency has announced an innovation challenge to spur development of medical devices, including digital health and diagnostic devices, to help combat opioid addiction. #FDAIn

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As part of FDA’s ongoing effort to address the epidemic of #opioid addiction, the agency has announced an innovation challenge to spur development of medical devices, including digital health and diagnostic devices, to help combat opioid addiction. #FDAInnovationChallenge pic.twitter.com/W21hFOinRg

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Baxalta Innovations GmbH)

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Europe -DG Health and Food Safety