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lifeline endocardial bipolar lead 476-06
Intermedics
Summary: The Lifeline Endocardial Bipolar Lead 476-06 is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K853518 ↗
Decision Date
November 5, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Endocardial Bipolar Lead 476-06 was cleared through the FDA 510(k) pathway on November 5, 1985. Manufactured by Intermedics, it is a Class III medical device.
What It Is
The Lifeline Endocardial Bipolar Lead 476-06 is a cardiac lead designed for use in pacemaker systems. It functions by transmitting electrical signals from the pacemaker to the heart, ensuring proper cardiac rhythm. The bipolar design allows for more precise signal delivery and reduced interference, which is critical in maintaining effective pacing.
Clinical Applications
This device is commonly used in the management of patients with bradycardia or other conditions requiring cardiac pacing. It is typically utilized in cardiology and electrophysiology settings, including hospitals and specialized cardiac care centers. The device is suitable for adult patients who require long-term pacing support.
Indications for Use
The Lifeline Endocardial Bipolar Lead 476-06 is indicated for patients who need cardiac pacing due to conditions like heart block or sick sinus syndrome. It helps maintain an adequate heart rate in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker systems. Proper placement technique is crucial to ensure effective pacing and minimize complications. Clinicians should be familiar with lead insertion and fixation techniques.
Frequently Asked Questions
What is Lifeline Endocardial Bipolar Lead 476-06 used for?
It is used for cardiac pacing in patients with conditions like heart block or bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions such as heart block or sick sinus syndrome.
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.