LEAD 439888 MRI STRAIGHT US


Product Overview

LEAD 439888 MRI STRAIGHT US
Attain Performa™ Straight MRI SureScan™ - 439888


Device Description

An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 59.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 77.00
    • 77.00

  • Device Sizes

  • Length: 88.0 Centimeter
    • Length: 88.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OJX

    Device Name: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    Device Class: 3

    Physical State: The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a CRT device and the other end located in a left cardiac vein.

    Definition: Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Used as part of an implantable crt system.

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Makes contact with the lv via the left cardiac vein.

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Code: DTB

    Device Name: Permanent Pacemaker Electrode

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 870.3680

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00643169601857

    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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