Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
Abbott Medical Australia Pty Ltd
AIMD
St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America
35852 - Defibrillator, implantable, automatic
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.
A
2013-03-19
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 সম্পূর্ণ নথি পড়ুন