Quadra Assura CD3367-40QC - 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 Quadra Assura CD3367-40QC 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 quadripolar pacing with Single Site Pacing. It features a DF4 device header and Parylene coating. The Quadra Assura CD3367-40QC 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. This device is MR conditional.

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,
LLC and its related companies.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, LLC. All Rights Reserved.
1
Device Description
This manual describes the following St. Jude Medical™
pulse generators
1
:
CAUTION: Not all device models are available in all countries.
Not all of the products listed as MR Conditional are approved for MR
Conditional use in
all countries or regions.
Before performing an MRI scan on patients implanted with any of these
devices,
contact St. Jude Medical or consult your regulatory authorities to
determine if the
products have been certified as MR Conditional.
Table 1. Single-chamber pulse generator descriptions
Name
Model
Number
Description
Connector
Type
Delivered
Energy
(approx.)
MRI Status
Ellipse VR
CD1275-36
Single-chamber ICD with
RF telemetry
DF-1/IS-1
36 J
Untested
1
Not all device models are available in all countries.
2
Table 1. Single-chamber pulse generator descriptions
Name
Model
Number
Description
Connector
Type
Delivered
Energy
(approx.)
MRI Status
Ellipse VR
CD1275-36Q
Single-chamber ICD with
RF telemetry
DF4-LLHH
2
36 J
Untested
Fortify
Assura VR
CD1359-40
Single-chamber ICD with
RF telemetry
DF-1/IS-1
40 J
Untested
Fortify
Assura VR
CD1359-40C
Single-chamber ICD with
RF telemetry, Parylene
coating
DF-1/IS-1
40 J
Untested
Fortify
Assura VR
CD1359-40Q
Single-chamber ICD with
RF telemetry
DF4-LLHH
40 J
MR
Conditional
Fortify
Assura VR
CD1359-40QC
Single-chamber ICD with
RF telemetry, Parylene
coating
DF4-LLHH
40 J
MR
Conditional