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model 479-01 pacing lead
Intermedics
Summary: The Model 479-01 pacing lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K844271 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 479-01 pacing lead was cleared through the FDA 510(k) pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class 3 device.
What It Is
The Model 479-01 pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker, which generates the impulses that the lead then delivers to the heart muscle. This device is crucial for patients with arrhythmias or heart block, ensuring that their heart maintains a regular rhythm.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. It is used in procedures to implant pacemakers in patients with bradycardia or other rhythm disorders. The device is suitable for adult patients who require long-term pacing therapy, often in hospital or specialized cardiac care units.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is used to ensure the heart beats at a regular rate, preventing symptoms like dizziness or fainting.
Practical Considerations
The Model 479-01 pacing lead typically comes in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Clinicians should be familiar with the implantation technique and ensure proper lead placement for optimal performance.
Frequently Asked Questions
What is the Model 479-01 pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, especially those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring 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.