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model 476-03 pacing lead
Intermedics
Summary: The model 476-03 pacing lead is a cardiac device used to deliver electrical impulses to the heart. It's primarily used by cardiologists in settings like hospitals and cardiac clinics for patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K844260 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 476-03 pacing lead was cleared through the FDA 510k pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class 3 medical device.
What It Is
The model 476-03 pacing lead is a component of a cardiac pacing system. It is designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The lead is implanted into the heart and connected to a pacemaker device, which regulates the heartbeat in patients with arrhythmias or heart block.
Clinical Applications
This pacing lead is commonly used in cardiology for patients with bradycardia or heart block. It is typically implanted during a pacemaker insertion procedure in a hospital setting. Patients who benefit from this device often include those with symptomatic arrhythmias, requiring consistent heart rate regulation.
Indications for Use
The FDA indications suggest this device is for patients with conditions that require pacing therapy, such as heart block or slow heart rhythms. It is intended for those who need electrical stimulation to maintain an adequate heart rate.
Practical Considerations
The model 476-03 pacing lead is compatible with various pacemaker models. Clinicians should consider the lead's length and diameter for proper fit and function. Implantation requires careful technique to ensure secure placement and optimal performance.
Frequently Asked Questions
What is the model 476-03 pacing lead used for?
It is used to deliver electrical impulses to the heart to regulate heart rhythm in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and cardiac clinic settings.
What are the FDA-cleared indications?
The device is indicated for patients needing pacing therapy, such as those with heart block or bradycardia.
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.