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polysafe tm implantable pacing lead
Cardiac Control Systems
Summary: The Polysafe TM Implantable Pacing Lead is a cardiac device used to deliver electrical impulses to the heart for pacing. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K884024 ↗
Decision Date
October 14, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polysafe TM Implantable Pacing Lead was cleared through the FDA 510k pathway on October 14, 1988, by Cardiac Control Systems. It is classified as a Class III medical device.
What It Is
The Polysafe TM Implantable Pacing Lead is a medical device designed to provide electrical stimulation to the heart muscle to maintain an adequate heart rate. It consists of a lead wire that connects to a pacemaker and delivers impulses directly to the heart tissue. This device is crucial for patients with arrhythmias or heart block, ensuring proper cardiac function.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. It is implanted in patients with bradycardia or other conduction disorders requiring pacing. The device is typically used in hospital settings during pacemaker implantation procedures, often in patients with symptomatic heart rhythm disorders.
Indications for Use
The FDA indications for this device include use in patients who require cardiac pacing due to conditions like heart block or bradycardia. It is intended for individuals who need consistent electrical stimulation to maintain heart rhythm.
Practical Considerations
The Polysafe TM Implantable Pacing Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Implantation requires careful technique to ensure proper lead placement and function.
Frequently Asked Questions
What is Polysafe TM Implantable Pacing Lead used for?
It is used to deliver electrical impulses to the heart to maintain a proper heart rate in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically 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.