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model 483-01 pacing lead
Intermedics
Summary: The Model 483-01 pacing lead by Intermedics is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists for patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K844262 ↗
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 to the heart to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker. The lead is implanted into the heart muscle and connected to the pacemaker, which sends the necessary electrical signals to regulate the heart's rhythm.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in patients with bradycardia or heart block who require pacing support. It is used in both hospital and outpatient settings, often during procedures performed by electrophysiologists or cardiologists. The device is suitable for adult patients who need long-term cardiac pacing.
Indications for Use
The FDA indications suggest that this device is intended for patients who require cardiac pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm in patients whose hearts are unable to do so naturally.
Practical Considerations
When using the Model 483-01 pacing lead, clinicians should consider the appropriate lead length and compatibility with the chosen pacemaker model. Proper implantation technique is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is the Model 483-01 pacing lead used for?
It is used to deliver electrical impulses to the heart for patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing, such as those with 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.