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intermedics polyflex-model 483-03 lead
Intermedics
Summary: The Intermedics Polyflex-Model 483-03 Lead is a cardiac pacing lead used in conjunction with pacemakers. It is primarily utilized by cardiologists and electrophysiologists to manage arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K812990 ↗
Decision Date
November 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Polyflex-Model 483-03 Lead was cleared via the FDA 510(k) pathway on November 16, 1981. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics Polyflex-Model 483-03 Lead is a flexible, insulated wire used to connect a pacemaker to the heart muscle. It transmits electrical impulses from the pacemaker to the heart to regulate heartbeats. This lead is designed for durability and reliable performance in long-term cardiac pacing therapy.
Clinical Applications
This lead is commonly used in cardiac pacing procedures, particularly in patients with bradycardia or heart block. It is typically implanted in hospital settings by cardiologists or electrophysiologists. The device is suitable for adult patients requiring chronic pacing support.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like bradycardia or atrioventricular block. It helps maintain adequate heart rate and rhythm in these patients.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with a range of pacemaker models. Proper implantation technique is crucial for optimal performance and longevity.
Frequently Asked Questions
What is the Intermedics Polyflex-Model 483-03 Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The lead is indicated for patients requiring cardiac pacing due to conditions like 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.