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CARDIOVASCULAR
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DECLARATIONS OF CONFORMITY (DOC) FOR EUROPEAN UNION RADIO EQUIPMENT DIRECTIVE (RED)

The following Abbott product(s) conform to the applicable provisions of the Radio Equipment Directive (2014/53/EU). All supporting documentation is retained under the premises of Abbott. This declaration is issued under the sole responsibility of the manufacturer. This declaration supersedes any declaration issued previously for the same product(s).

Each document may contain the following translations: English, Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Turkish.

Visit the Neuromodulation Declarations of Conformity website to view European Union Radio Equipment Directive (RED) Declarations of Conformity for Neuromodulation products.

CARDIAC RHYTHM MANAGEMENT

IMPLANTABLE PACEMAKERS AND CRT-P DEVICES

Low Voltage RF

Accent™, Accent MRI™
Allure™, Allure Quadra™
Anthem™
Assurity™, Assurity MRI™
Quadra Allure™

Low Voltage non-RF (Inductive)

Accent, Accent MRI
Allure, Allure Quadra
Anthem
Endurity™, Endurity Core, Endurity MRI™
Sustain™
Verity™
Zephyr™

Microny™

IMPLANTABLE ICD AND CRT-D DEVICES

High Voltage

Ellipse™
Fortify™, Fortify Assura™
Quadra Assura™
Unify™, Unify Quadra™, Unify Assura™

IMPLANTABLE CARDIAC MONITORS

Confirm RX™

SJM™ Confirm™

ELECTROPHYSIOLOGY

MAPPING AND VISUALIZATION

Ensite™ Systems

Ensite X EP System

EnSite Velocity™ cardiac mapping system
EnSite Precision™ Module, Sensor Enabled™

MediGuide™ Technology

HEART FAILURE

CardioMEMS™ HF System

CardioMEMS hospital electronics system
CardioMEMS i3 patient electronics system
CardioMEMS PA sensor and delivery catheter

HeartMate Touch™ Communication System

VASCULAR

PressureWire™ Guidewire

PressureWire Aeris with Agile Tip,
PressureWire X Wireless Connection

PresssureWire Guidewire Accessories

Wi-Box™ AO Transmitter
AO USB Receiver
PW USB Receiver

PressureWire Receiver

OPTIS™ Systems

ILUMIEN™ OPTIS system
OPTIS Integrated System
OPTIS Mobile System

QUANTIEN™ Measurement System

MAT-2005676 v2.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.