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ela medical pacing leads pmc 860 pmcf 860 pbcf860
Ela Medical
Summary: Ela Medical pacing leads are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists in patients requiring cardiac pacing due to arrhythmias or heart block.
FDA Clearance Information
Pathway
510K
Number
K851731 ↗
Decision Date
August 29, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Ela Medical pacing leads received FDA clearance via the 510(k) pathway on August 29, 1985. Manufactured by Ela Medical, these leads are classified as Class III devices under the product code DTB.
What It Is
Ela Medical pacing leads are components of cardiac pacemaker systems. They are designed to transmit electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. These leads are typically implanted transvenously and are crucial for patients with conditions like bradycardia or heart block, where the heart's natural pacing is inadequate.
Clinical Applications
These pacing leads are commonly used in cardiology, particularly in electrophysiology labs and during cardiac surgery. They are essential for patients with symptomatic bradycardia, heart block, or other arrhythmias that necessitate artificial pacing. The leads are used in both acute hospital settings and long-term management of chronic cardiac conditions.
Indications for Use
The FDA indications for Ela Medical pacing leads include use in patients who require electrical pacing of the heart due to conditions like heart block or bradycardia. These leads help maintain adequate heart rate and rhythm in patients whose natural pacemaker is not functioning properly.
Practical Considerations
Ela Medical pacing leads come in various lengths and configurations to accommodate different patient anatomies and clinical needs. They are compatible with a range of pacemaker devices. Proper technique during implantation is crucial to ensure lead stability and function.
Frequently Asked Questions
What is Ela Medical pacing leads used for?
Ela Medical pacing leads are used to deliver electrical impulses to the heart in patients requiring cardiac pacing due to arrhythmias or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, and cardiac surgeons typically use these pacing leads.
What are the FDA-cleared indications?
The leads are indicated for use in patients requiring electrical pacing of the heart, such as those with 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.