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model 483-03 pacing lead
Intermedics
Summary: The model 483-03 pacing lead by Intermedics is a cardiac pacing device used to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K844268 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 483-03 pacing lead was cleared by the FDA via the 510k pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The model 483-03 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, which generates the impulses. The lead is implanted into the heart muscle and connected to the pacemaker, allowing for continuous cardiac monitoring and pacing.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in patients with arrhythmias or heart block who require artificial pacing to maintain heart function. It is often used in hospital settings during pacemaker implantation procedures. The device is suitable for adult patients who have conditions that compromise their heart's ability to maintain a regular rhythm.
Indications for Use
The pacing lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It helps in maintaining a regular heart rhythm when the heart's natural pacemaker is not functioning properly.
Practical Considerations
When using the model 483-03 pacing lead, clinicians should consider the appropriate lead length and compatibility with the pacemaker device. Proper implantation technique is crucial to ensure optimal performance and reduce complications.
Frequently Asked Questions
What is the model 483-03 pacing lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation 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.