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lifeline endocardial unipolar 487-06 tle lead
Intermedics
Summary: The Lifeline Endocardial Unipolar 487-06 TLE Lead is a cardiac pacing lead used in patients requiring temporary or permanent pacing. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K853520 ↗
Decision Date
October 8, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Endocardial Unipolar 487-06 TLE Lead was cleared via the FDA 510k pathway on October 8, 1985. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The Lifeline Endocardial Unipolar 487-06 TLE Lead is a cardiac pacing lead designed for use in temporary or permanent cardiac pacing systems. It functions by delivering electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The unipolar design means it uses a single electrode to transmit the pacing signal, which can be beneficial in certain clinical scenarios.
Clinical Applications
This device is commonly used in cardiology and electrophysiology to manage arrhythmias in patients who require pacing support. It is often utilized in hospital settings, particularly in cardiac care units, for patients with bradycardia or heart block. The lead is suitable for both temporary and permanent pacing, making it versatile for different patient needs.
Indications for Use
The FDA indications suggest this lead is intended for patients who need electrical pacing of the heart due to conditions like bradycardia or heart block. It is suitable for those who require either temporary or permanent pacing solutions.
Practical Considerations
When using the Lifeline Endocardial Unipolar 487-06 TLE Lead, clinicians should consider the appropriate lead length and compatibility with the pacemaker system. The unipolar design may require specific implantation techniques and considerations for optimal performance.
Frequently Asked Questions
What is the Lifeline Endocardial Unipolar 487-06 TLE Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring electrical pacing of the heart due to conditions like bradycardia or heart block.
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.