ICD-DR DDBC3D1 EVERA S US DF1


Product Overview

ICD
Evera™ S DR - DDBC3D1


Device Description

A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 131.00
    • 0.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LWS

    Device Name: Implantable Cardioverter Defibrillator (Non-Crt)

    Device Class: 3

    Physical State: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

    Definition: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00643169929159

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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