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lifeline endocardial unipolar lead 483-08
Intermedics
Summary: The Lifeline Endocardial Unipolar Lead 483-08 is a cardiac pacing lead used in conjunction with pacemakers. It is primarily used by cardiologists in hospital settings for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K853517 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Endocardial Unipolar Lead 483-08 was cleared through the FDA 510(k) pathway on December 4, 1985. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The Lifeline Endocardial Unipolar Lead 483-08 is a cardiac pacing lead designed to deliver electrical impulses from a pacemaker to the heart muscle. It is unipolar, meaning it has a single electrode at the tip that contacts the heart tissue. This lead is implanted endocardially, which involves threading it through a vein into the heart, where it helps maintain appropriate heart rhythm in patients with arrhythmias.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other rhythm disorders. Cardiologists and electrophysiologists typically use this lead in hospital settings, especially in cardiac catheterization labs. It is suitable for adult patients who require long-term cardiac pacing support.
Indications for Use
The Lifeline Endocardial Unipolar Lead 483-08 is indicated for patients who need cardiac pacing due to arrhythmias such as bradycardia. It is used in conjunction with a pacemaker to ensure the heart maintains a regular rhythm.
Practical Considerations
When using the Lifeline Endocardial Unipolar Lead 483-08, clinicians should consider the lead's compatibility with the pacemaker system being used. Proper sizing and placement technique are crucial for optimal performance and patient safety. Regular follow-up is necessary to monitor lead function and patient response.
Frequently Asked Questions
What is the Lifeline Endocardial Unipolar Lead 483-08 used for?
It is used for cardiac pacing in patients with arrhythmias, delivering electrical impulses from a pacemaker to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly for patients requiring cardiac rhythm management.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to arrhythmias like bradycardia, used in conjunction with a pacemaker.
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.