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model 480-01 pacing lead
Intermedics
Summary: The Model 480-01 pacing lead is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists in settings like hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway
510K
Number
K844270 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 480-01 pacing lead by Intermedics was cleared through the FDA 510(k) pathway on March 28, 1985. It is classified as a Class III device under product code DTB.
What It Is
The Model 480-01 pacing lead is a medical device designed to provide electrical stimulation to the heart, ensuring proper cardiac rhythm. It is typically used in conjunction with a pacemaker, where the lead acts as a conduit for electrical signals from the pacemaker to the heart muscle. This device is crucial for patients with arrhythmias or heart blockages, helping to maintain a stable heart rate.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in procedures involving pacemaker implantation. It is suitable for patients with bradycardia or heart block, where consistent electrical pacing is necessary. The device is typically used in hospital settings, including operating rooms and cardiac catheterization labs, and is handled by cardiologists and electrophysiologists.
Indications for Use
The FDA indications for the Model 480-01 pacing lead include its use in patients requiring cardiac pacing due to arrhythmias or heart block. It is intended for individuals who need assistance in maintaining a regular heart rhythm.
Practical Considerations
The Model 480-01 pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices. Proper placement and secure fixation are critical for optimal performance, requiring careful technique during implantation.
Frequently Asked Questions
What is the Model 480-01 pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular rhythm in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, especially in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to arrhythmias 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.