Unify Assura CD3361-40 - Defibrillator, implantable, automatic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abbott Medical Australia Pty Ltd

Class:

AIMD

Manufactured by:

St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America

Therapeutic area:

35852 - Defibrillator, implantable, automatic

Therapeutic indications:

The Unify Assura CD3361-40 is a cardiac resynchronisation therapy device with RF telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and Single Site Pacing. It features an IS-1/DF-1 device header. The Unify Assura CD3361-40 is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy devices (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF.

Authorization status:

A

Authorization date:

2013-03-19

Summary of Product characteristics

Ellipse™
Tiered-therapy Cardioverter/Defibrillator
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™, Quadra Assura MP™
Cardiac Resynchronization Device, Tiered-therapy
Cardioverter/Defibrillator
Unify Assura™
Cardiac Resynchronization Device, Tiered-therapy
Cardioverter/Defibrillator
Unless otherwise noted, ™ indicates that the name is a trademark of,
or licensed to, St. Jude Medical or one of its subsidiaries.
ST. JUDE MEDICAL and the nine-squares symbol are trademarks and
service marks of St. Jude Medical, Inc. and its related
companies. © 2015 St. Jude Medical, Inc. All Rights Reserved.
1
Device Description
This manual describes the following St. Jude Medical™
pulse generators
1
:
Table 1. Single-chamber pulse generator descriptions
Name
Model
Number
Description
Connector
Type
Delivered Energy
(approx.)
MRI Status
Fortify Assura VR
CD1257-40
Single-chamber ICD with RF
telemetry
DF-1/IS-1
40 J
Untested
Fortify Assura VR
CD1257-40Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
40 J
Untested
Fortify Assura VR
CD1259-40
Single-chamber ICD with RF
telemetry
DF-1/IS-1
40 J
Untested
Fortify Assura VR
CD1259-40Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
40 J
Untested
Fortify Assura VR
CD1261-40
Single-chamber ICD with RF
telemetry
DF-1/IS-1
40 J
Untested
Fortify Assura VR
CD1261-40Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
40 J
Untested
Ellipse VR
CD1275-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36 J
Untested
Ellipse VR
CD1275-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
2
36 J
Untested
Ellipse VR
CD1277-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36 J
Untested
Ellipse VR
CD1277-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
36 J
Untested
Ellipse VR
CD1279-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36 J
Untested
Ellipse VR
CD1279-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
36 J
Untested
Ellipse VR
CD1311-36Q
Single-chamber ICD with RF
telemetry
DF4-LLHH
36 J
Untested
Ellipse VR
CD1311-36
Single-chamber ICD with RF
telemetry
DF-1/IS-1
36