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intermedics polyflex-model 493-03 lead
Intermedics
Summary: The Intermedics Polyflex-Model 493-03 Lead is a medical device used in cardiac procedures, specifically for pacing. It is utilized by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K812989 ↗
Decision Date
November 16, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Polyflex-Model 493-03 Lead was cleared through the FDA 510k pathway on November 16, 1981. It is manufactured by Intermedics and classified as a Class III device.
What It Is
The Intermedics Polyflex-Model 493-03 Lead is a cardiac pacing lead designed to transmit electrical impulses from a pacemaker to the heart. It plays a crucial role in maintaining heart rhythm in patients with arrhythmias. The lead is typically implanted in the heart's ventricle and is compatible with various pacemaker models.
Clinical Applications
This lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists in electrophysiology labs or cardiac surgery settings frequently use this device. It is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like slow heart rate or heart block. It helps ensure the heart maintains an adequate rhythm.
Practical Considerations
The Polyflex-Model 493-03 Lead is available in various lengths to accommodate different patient anatomies. It is important to ensure compatibility with the pacemaker system being used. Proper implantation technique is crucial for optimal performance and longevity.
Frequently Asked Questions
What is the Intermedics Polyflex-Model 493-03 Lead used for?
It is used for cardiac pacing in patients with arrhythmias, helping to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in 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.