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lifeline endocardial bipolar lead 484-03
Intermedics
Summary: The Lifeline Endocardial Bipolar Lead 484-03 is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K853519 ↗
Decision Date
October 24, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Endocardial Bipolar Lead 484-03 was cleared through the FDA 510(k) pathway on October 24, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Lifeline Endocardial Bipolar Lead 484-03 is a specialized cardiac lead designed for use in pacemaker systems. It functions by transmitting electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The bipolar design allows for more precise sensing and pacing, which is crucial for effective cardiac management.
Clinical Applications
This device is commonly used in the management of arrhythmias, particularly in patients requiring long-term pacing support. It is typically utilized in cardiology departments within hospitals and specialized cardiac care centers. The lead is suitable for adult patients who have been diagnosed with conditions such as bradycardia or heart block.
Indications for Use
The FDA indications suggest this device is intended for patients who need cardiac pacing due to irregular heart rhythms. It is specifically used in scenarios where electrical impulses are necessary to maintain a stable heart rate.
Practical Considerations
The Lifeline Endocardial Bipolar Lead 484-03 is compatible with most pacemaker systems. Clinicians should ensure proper lead placement and secure connections to optimize device performance. Sizing and compatibility with existing systems should be verified before implantation.
Frequently Asked Questions
What is the Lifeline Endocardial Bipolar Lead 484-03 used for?
It is used for cardiac pacing in patients with arrhythmias, such as bradycardia, to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and specialized cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to irregular heart rhythms, such as 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.