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model 484-01 bipolar coaxial pacing lead
Intermedics
Summary: The Model 484-01 Bipolar Coaxial Pacing Lead is a medical device used in cardiac pacing procedures. It is primarily used by cardiologists and electrophysiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K791377 ↗
Decision Date
September 12, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 484-01 Bipolar Coaxial Pacing Lead was cleared by the FDA via the 510k pathway on September 12, 1979. Manufactured by Intermedics, it is classified as a Class 3 device.
What It Is
The Model 484-01 is a bipolar coaxial pacing lead designed for use in cardiac pacing. It functions by delivering electrical impulses from a pacemaker to the heart muscle, helping to maintain an adequate heart rate in patients with arrhythmias. The coaxial design refers to its structure, which enhances durability and reliability in transmitting electrical signals.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically use it in hospital settings, including operating rooms and cardiac catheterization labs. It is suitable for adult and pediatric patients requiring long-term cardiac pacing.
Indications for Use
The device is indicated for patients who require electrical pacing of the heart due to conditions like bradycardia or atrioventricular block. It helps in maintaining an appropriate heart rate when the heart's natural pacemaker is not functioning properly.
Practical Considerations
The Model 484-01 pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemaker generators. Proper technique during implantation is crucial to ensure optimal lead positioning and function.
Frequently Asked Questions
What is the Model 484-01 Bipolar Coaxial Pacing Lead used for?
It is used for cardiac pacing in patients with heart rhythm disorders such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring electrical pacing of the heart 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.