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model 473-03 pacing lead
Intermedics
Summary: The model 473-03 pacing lead by Intermedics is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K844272 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 473-03 pacing lead was cleared through the FDA 510(k) pathway on March 28, 1985. It is manufactured by Intermedics and classified as a Class III device.
What It Is
The model 473-03 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. The lead is implanted in the heart and connected to the pacemaker, which regulates the heart's rhythm and rate.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in patients with bradycardia or heart block who require pacing to maintain a regular heartbeat. It is used in hospital settings, often in cardiac catheterization labs or operating rooms. The device is suitable for adult and pediatric patients who need long-term cardiac pacing.
Indications for Use
The FDA indications for the model 473-03 pacing lead include use in patients with arrhythmias that require pacing to maintain heart function. It is indicated for conditions like bradycardia and heart block.
Practical Considerations
The model 473-03 pacing lead is typically available in various lengths to accommodate different patient anatomies. It is compatible with most standard pacemakers. Clinicians should ensure proper positioning and secure fixation during implantation to prevent lead dislodgement.
Frequently Asked Questions
What is the model 473-03 pacing lead used for?
It is used to deliver electrical impulses to the heart in patients who require cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients with arrhythmias such as bradycardia and heart block that require pacing.
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.