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model 483-02 pacing lead
Intermedics
Summary: The Model 483-02 pacing lead is a cardiac device used for pacing the heart. It is primarily utilized by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K844269 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 483-02 pacing lead was cleared through the FDA 510(k) pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 483-02 pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker. The lead is inserted into the heart via a vein and is crucial for patients with arrhythmias or heart block.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is indicated for patients with bradycardia or heart block who require pacing support. The device is suitable for both temporary and permanent pacing scenarios, depending on the patient's condition.
Indications for Use
The FDA indications suggest that the pacing lead is intended for patients who need cardiac pacing due to conditions like slow heart rhythms or heart block. It helps ensure the heart beats at a regular rate.
Practical Considerations
Clinicians should consider the lead's compatibility with various pacemaker models. Proper sizing and placement technique are critical for optimal performance and patient safety. Typically, the lead is available in different lengths to accommodate anatomical variations.
Frequently Asked Questions
What is Model 483-02 pacing lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block to maintain a regular heart rate.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to slow heart rhythms 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.