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lifeline unipolar j-lead 483-05
Intermedics
Summary: The Lifeline Unipolar J-Lead 483-05 is a cardiac lead used in pacemaker systems. It is typically used by cardiologists to manage arrhythmias in patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K830463 ↗
Decision Date
February 28, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Unipolar J-Lead 483-05 was cleared through the FDA 510(k) pathway on February 28, 1983. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Lifeline Unipolar J-Lead 483-05 is a cardiac pacing lead designed for use in conjunction with pacemakers. It features a unipolar configuration, which means it has a single electrode for delivering electrical impulses to the heart. The 'J' shape of the lead is designed to facilitate placement in the right atrium or ventricle, ensuring stable contact with cardiac tissue.
Clinical Applications
This lead is commonly used in cardiac electrophysiology and cardiology settings, particularly in the implantation of pacemaker systems. It is suitable for patients with bradycardia or other rhythm disturbances that require electrical pacing. The device is typically used in hospital settings, including operating rooms and cardiac catheterization labs, by cardiologists and electrophysiologists.
Indications for Use
The Lifeline Unipolar J-Lead 483-05 is indicated for patients who require pacing due to arrhythmias such as bradycardia. It is used in individuals who need a reliable method to maintain adequate heart rate and rhythm.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with a range of pacemaker devices. Proper technique during implantation is crucial to ensure optimal placement and function. Clinicians should be familiar with the specific handling and insertion techniques for unipolar leads.
Frequently Asked Questions
What is Lifeline Unipolar J-Lead 483-05 used for?
It is used in pacemaker systems to deliver electrical impulses to the heart in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring pacing due to arrhythmias such as bradycardia.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.