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endocardial pacing lead model 476-01
Intermedics
Summary: The endocardial pacing lead model 476-01 by Intermedics is a device used in cardiac pacing procedures. It is primarily used by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K790548 ↗
Decision Date
June 1, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial pacing lead model 476-01 was cleared through the FDA 510k pathway on June 1, 1979. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The endocardial pacing lead model 476-01 is a cardiac device designed to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm in patients with arrhythmias. It is implanted within the heart's endocardial surface and connects to a pacemaker. The lead facilitates the transmission of electrical signals from the pacemaker to the heart, helping to maintain an adequate heart rate.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology settings, for patients who require long-term pacing support due to bradycardia or other rhythm disorders. It is typically used in hospital settings during pacemaker implantation procedures. The patient population includes those with symptomatic bradycardia, heart block, or other conditions necessitating pacing support.
Indications for Use
The endocardial pacing lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is used to ensure that the heart maintains a regular rhythm when the body's natural pacemaker is not functioning properly.
Practical Considerations
When using the endocardial pacing lead, clinicians should consider the lead's compatibility with various pacemaker models. Proper sizing and placement technique are crucial for optimal performance and patient outcomes. The lead is designed for long-term implantation, requiring careful handling during insertion.
Frequently Asked Questions
What is endocardial pacing lead model 476-01 used for?
It is used for cardiac pacing in patients with arrhythmias, ensuring proper heart rhythm.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, use this device in pacemaker implantation procedures.
What are the FDA-cleared indications?
It is indicated for patients needing 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.