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polyflex 493-07 endocardial implantable pac-lead
Intermedics
Summary: The Polyflex 493-07 is an endocardial implantable pacemaker lead used in cardiac pacing. It is utilized by cardiologists for patients requiring heart rhythm management.
FDA Clearance Information
Pathway
510K
Number
K854071 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polyflex 493-07 received FDA clearance through the 510(k) pathway on December 4, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Polyflex 493-07 is an endocardial implantable pacemaker lead designed to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker device. The lead is implanted into the heart's endocardial surface and is connected to the pacemaker, which regulates the heart's electrical activity.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology, to treat patients with bradycardia or other arrhythmias requiring pacing. It is typically used in hospital settings during cardiac procedures. The patient population includes those with heart block, sick sinus syndrome, or other conditions leading to inadequate heart rate.
Indications for Use
The Polyflex 493-07 is indicated for patients who require cardiac pacing due to conditions like heart block or bradycardia. It is suitable for individuals who need long-term pacing support to maintain heart function.
Practical Considerations
The Polyflex 493-07 is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices. Clinicians should ensure proper lead placement and secure connection to the pacemaker for optimal performance.
Frequently Asked Questions
What is Polyflex 493-07 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, particularly those specializing in electrophysiology, use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions like heart block or 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.