Optisure IS-1/DF-1, Passive Fixation, Dual Coil Leads models LDP220 & LDP230 - Lead, defibrillator/pacemaker, implantable
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Abbott Medical Australia Pty Ltd
Class:
Class III
Manufactured by:
St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America
Therapeutic area:
36241 - Lead, defibrillator/pacemaker, implantable
Therapeutic indications:
For attachment to an implantable cardioverter defibrillator (ICD) with IS-1/DF-1 device header configuration. The leads have two defibrillation electrodes on in the distal portion to provide true bipolar rate sensing, pacing and delivery of cardioversion/defibrillation shocks. For use with compatible pulse generators to provide pacing, sensing and deliver cardioversion / defibrillation therapy to the heart.
Authorization status:
A
Authorization date:
2014-03-11
