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model 483-01 pacing lead
Intermedics
Summary: The model 483-01 pacing lead by Intermedics is a cardiac pacing lead used in conjunction with pacemakers to manage heart rhythm disorders. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K844267 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 483-01 pacing lead was cleared through the FDA 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 483-01 pacing lead is a medical device designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It is typically inserted transvenously and positioned within the heart chambers. The lead is essential for patients with arrhythmias who require consistent cardiac pacing.
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 in hospital settings frequently use this device. It is suitable for adult patients who require long-term cardiac pacing support.
Indications for Use
The device is indicated for patients with heart rhythm disorders such as bradycardia, where the heart beats too slowly. It helps maintain an adequate heart rate by delivering electrical impulses directly to the heart.
Practical Considerations
The model 483-01 pacing lead is compatible with a range of pacemakers. It is important to ensure proper sizing and positioning during implantation to optimize performance and reduce complications. Clinicians should be familiar with transvenous lead placement techniques.
Frequently Asked Questions
What is the model 483-01 pacing lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart, ensuring proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The pacing lead is indicated for use in patients with heart rhythm disorders such as bradycardia, where it helps maintain an adequate heart rate.
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.