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polyflex implantable pacing lead-476-07
Intermedics
Summary: The Polyflex Implantable Pacing Lead is a cardiac pacing lead used in patients requiring cardiac pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K853521 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Polyflex Implantable Pacing Lead by Intermedics was cleared through the FDA 510k pathway on December 4, 1985. It is a Class III medical device.
What It Is
The Polyflex Implantable Pacing Lead is a device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is implanted into the heart muscle and connected to a pacemaker. The lead is crucial for patients with arrhythmias or heart block, ensuring the heart beats at a regular pace.
Clinical Applications
This device is commonly used in cardiology, particularly in procedures involving the implantation of pacemakers. It is used in patients with bradycardia or heart block who require consistent cardiac pacing. The device is typically implanted in a hospital setting, often in a cardiac catheterization lab or operating room.
Indications for Use
The FDA indications for this device include use in patients with heart rhythm disorders that require pacing. This typically involves conditions like bradycardia or atrioventricular block.
Practical Considerations
The Polyflex Implantable Pacing Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices, and proper implantation technique is crucial for optimal performance and longevity.
Frequently Asked Questions
What is the Polyflex Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients with heart rhythm disorders requiring pacing, such as 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.