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lifeline tle j-shaped atrial endocardial
Intermedics
Summary: The Lifeline TLE J-Shaped Atrial Endocardial is a cardiac device used for atrial pacing. It is primarily used by cardiologists in settings requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K792301 ↗
Decision Date
June 4, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline TLE J-Shaped Atrial Endocardial was cleared via the FDA 510(k) pathway on June 4, 1980. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Lifeline TLE J-Shaped Atrial Endocardial is a type of endocardial lead used in cardiac pacing systems. It features a J-shaped design to facilitate stable placement in the atrium. This device is integral to pacemaker systems, helping to maintain proper heart rhythm in patients with atrial arrhythmias.
Clinical Applications
This device is commonly used in electrophysiology and cardiology settings for patients requiring atrial pacing. It is typically used in procedures involving pacemaker implantation, particularly in patients with atrial fibrillation or other atrial arrhythmias. The device is suitable for use in both hospital and outpatient settings.
Indications for Use
The Lifeline TLE J-Shaped Atrial Endocardial is indicated for patients who require atrial pacing due to conditions like atrial fibrillation. It helps maintain a regular heart rhythm by delivering electrical impulses to the atrium.
Practical Considerations
The device is designed to be compatible with various pacemaker systems. Its J-shaped design aids in secure placement within the atrium, reducing the risk of lead dislodgement. Clinicians should ensure proper sizing and compatibility with the patient's anatomy and the pacing system used.
Frequently Asked Questions
What is the Lifeline TLE J-Shaped Atrial Endocardial used for?
It is used for atrial pacing in patients with atrial arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing atrial pacing, such as those with atrial fibrillation.
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.