Sentus

Main information

  • Trade name:
  • Sentus OTW UP H - Lead, defibrillator/pacemaker, implantable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sentus OTW UP H - Lead, defibrillator/pacemaker, implantable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219381
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219381

Biotronik Australia Pty Ltd - Sentus OTW UP H - Lead, defibrillator/pacemaker, implantable

ARTG entry for

Medical Device Included Class III

Sponsor

Biotronik Australia Pty Ltd

Postal Address

Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

20/01/2014

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

Biotronik SE & Co KG

Woermannkehre 1

, Berlin, 12359

Germany

Products

1. Sentus OTW UP H - Lead, defibrillator/pacemaker, implantable

Product Type

Single Device Product

Effective date

20/01/2014

GMDN

36241 Lead, defibrillator/pacemaker, implantable

Functional description

Sentus OTW UP H is unipolar passive fixation in a left ventricular coronary vessel by unfolding a

pre-shaped helix and contains dexamethasone acetate. It is guided into the target vein using either the

OTW technique or a stylet. A seal at the lead tip prevents blood from penetrating the inner lumen of the

lead. Pacing is performed through a tip electrode; the contact surface has a fractal iridium coating. The

silicone insulation is coated improving gliding properties

Intended purpose

Sentus OTW UP H lead is a permanent, transvenous implantation in the coronary venous system via the

coronary sinus. It is component of an integrated system for long-term cardiac pacing, together with a

BIOTRONIK implantable triple-chamber pacemaker or ICD as part of cardiac resynchronization therapy

(CRT)

Variant information

Model number (see guidance docs) Sentus OTW

UP H 75

Length (cm) 75 (77 cm) - 95 (97) cm

Model number (see guidance docs) Sentus OTW

UP H 85

Model number (see guidance docs) Sentus OTW

UP H 95

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 23.11.2017 at 10:55:35 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