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model 482-01 bipolar coaxial pacing lead
Intermedics
Summary: The model 482-01 bipolar coaxial pacing lead is a medical device used in cardiac pacing procedures. It is primarily utilized by cardiologists for patients requiring temporary or permanent pacing support.
FDA Clearance Information
Pathway
510K
Number
K791378 ↗
Decision Date
September 12, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 482-01 bipolar coaxial pacing lead by Intermedics was cleared through the FDA 510k pathway on September 12, 1979. It is classified as a Class III device under product code DTB.
What It Is
The model 482-01 is a bipolar coaxial pacing lead designed for use in cardiac pacing. It functions by delivering electrical impulses to the heart muscle to maintain an adequate heart rate. The coaxial design allows for reliable signal transmission and durability, making it suitable for both temporary and permanent pacing applications.
Clinical Applications
This device is commonly used in cardiac pacing procedures, particularly in patients with bradycardia or heart block. It is typically utilized in hospital settings, including cardiac catheterization labs and operating rooms. Cardiologists and electrophysiologists are the primary users, and it is suitable for a wide range of patient populations requiring pacing support.
Indications for Use
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It helps maintain an adequate heart rate when the heart's natural pacemaker is not functioning properly.
Practical Considerations
The model 482-01 pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper lead placement and secure fixation are crucial for optimal performance and minimizing complications.
Frequently Asked Questions
What is the model 482-01 bipolar coaxial pacing lead used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block to maintain an adequate heart rate.
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 needing cardiac pacing due to 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.