5MAX

Main information

  • Trade name:
  • 5MAX Reperfusion Catheter - Embolectomy/thrombectomy suction catheter
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • 5MAX Reperfusion Catheter - Embolectomy/thrombectomy suction catheter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216903
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216903

Penumbra Neuro Australia Pty Ltd - 5MAX Reperfusion Catheter - Embolectomy/thrombectomy suction

catheter

ARTG entry for

Medical Device Included Class III

Sponsor

Penumbra Neuro Australia Pty Ltd

Postal Address

Suite 3 Level 5 / 1 Oxford Street,DARLINGHURST, NSW, 2010

Australia

ARTG Start Date

4/11/2013

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

Penumbra Inc

One Penumbra Place

Alameda, CA, 94502

United States Of America

Products

1. 5MAX Reperfusion Catheter - Embolectomy/thrombectomy suction catheter

Product Type

Single Device Product

Effective date

4/11/2013

GMDN

58173 Embolectomy/thrombectomy suction catheter

Functional description

The Penumbra System was designed to remove thrombus from large intracranial vessels by aspirating the

proximal side of the thrombus. The Reperfusion Catheter is introduced through a guide catheter or long

femoral sheath and into the intracranial vasculature and guided over a guidewire to the site of the primary

occlusion. The Penumbra Reperfusion Catheter is used in parallel with the Penumbra Separator and an

aspiration source to separate the thrombus and aspirate it from the occluded vessel.

Intended purpose

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke

secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ± M1

and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Variant information

Length (cm) 125-132

Shape (of tip) straight

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 03:58:04 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