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model 493-03 pacing lead
Intermedics
Summary: The model 493-03 pacing lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K844264 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 493-03 pacing lead, manufactured by Intermedics, was cleared by the FDA via the 510k pathway on March 28, 1985. It is classified as a Class 3 device under product code DTB.
What It Is
The model 493-03 pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an appropriate 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 regulates the heart's rhythm.
Clinical Applications
This pacing lead is commonly used in patients with bradycardia or other arrhythmias that require pacing support. It is typically utilized in cardiology settings, including hospitals and specialized cardiac care centers. The device is suitable for adult patients who need long-term cardiac rhythm management.
Indications for Use
The FDA indications suggest the device is used for patients with conditions that necessitate cardiac pacing, such as those with slow heart rates or heart block. It is intended for individuals who require consistent electrical stimulation to maintain heart rhythm.
Practical Considerations
The model 493-03 pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemakers and requires careful implantation technique to ensure proper function and minimize complications.
Frequently Asked Questions
What is the model 493-03 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 typically use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to arrhythmias like bradycardia.
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.