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lifeline endocardial pacing lead 479-05
Intermedics
Summary: The Lifeline Endocardial Pacing Lead 479-05 is a cardiac pacing lead used in pacemaker systems to maintain heart rhythm. It is used by cardiologists and electrophysiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K830782 ↗
Decision Date
April 18, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Endocardial Pacing Lead 479-05 was cleared through the FDA 510(k) pathway on April 18, 1983. It is manufactured by Intermedics and classified as a Class III medical device.
What It Is
The Lifeline Endocardial Pacing Lead 479-05 is a component of a cardiac pacing system, designed to deliver electrical impulses from a pacemaker to the heart muscle. It is an endocardial lead, meaning it is placed inside the heart via the venous system. The lead is crucial for ensuring proper electrical conduction and maintaining an adequate heart rate in patients with arrhythmias or heart block.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemaker systems, particularly in patients with bradycardia or heart block. It is typically utilized in hospital settings, including cardiac catheterization labs and operating rooms. Cardiologists and electrophysiologists are the primary specialists involved in these procedures, and the device is used across a wide range of adult patient populations.
Indications for Use
The FDA indications suggest that this device is used for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is intended for use in patients who need assistance in maintaining a regular heart rhythm.
Practical Considerations
When using the Lifeline Endocardial Pacing Lead 479-05, clinicians should consider the appropriate lead size for the patient's anatomy and ensure compatibility with the pacemaker generator. Proper technique during insertion is crucial to avoid complications such as lead dislodgement or infection.
Frequently Asked Questions
What is Lifeline Endocardial Pacing Lead 479-05 used for?
It is used to deliver electrical impulses from a pacemaker to the heart to maintain a regular heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the context of pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients who require cardiac pacing 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.