📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Atrial endocardial pacing as part of a compatible cardiac pacemaker system.
- Use in patients who require electrical stimulation of the atrium for cardiac rhythm management.
Clinical Applications
- Placement during implantation of a pacemaker system requiring an atrial lead.
- Endocardial pacing of the right atrium through a transvenous approach.
- Atrial rhythm management when electrical impulses must be delivered from an implanted pacing system.
Practical Considerations
- The J-shaped configuration is intended to support positioning and stability in the atrium; final placement is confirmed with fluoroscopy and electrical measurements.
- The lead must be matched to the compatible pacemaker generator, connector configuration, and patient anatomy.
- The FDA record supplied does not specify lead lengths, diameters, or a current MRI-conditional labeling status; clinicians should verify the original labeling and the complete implanted system before MRI.
- Potential complications of transvenous atrial lead placement include vascular injury, cardiac perforation, arrhythmia, infection, thrombosis, lead dislodgement, and loss of electrical capture.
- Use is contraindicated or limited when the patient cannot safely undergo transvenous lead placement or when the lead and generator are not compatible.
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.