Unify Assura CD3261-40Q - Defibrillator, implantable, automatic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

St Jude Medical Australia Pty Ltd

Class:

Medical Device Included AIMD

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