LEAD 429688 USA MKT 88CM


Product Overview

LEAD 429688 USA MKT 88CM
Attain Ability® Plus - 429688


Device Description

An implantable flexible 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 cardiac resynchronization therapy (CRT) pulse generator to the left ventricle of the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is introduced into a cardiac vein through transvenous approach via the coronary sinus. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues 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: 00613994719133

    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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