đź“‹ FDA Reference
model 431-06 polyflex implantable pacing lead
Intermedics
Summary: The Model 431-06 Polyflex Implantable Pacing Lead is used in cardiac pacing procedures to help manage arrhythmias. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K864002 ↗
Decision Date
November 20, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 431-06 Polyflex Implantable Pacing Lead by Intermedics was cleared through the FDA 510k pathway on November 20, 1986. It is a Class III medical device.
What It Is
The Model 431-06 Polyflex Implantable Pacing Lead is a device used in cardiac pacing systems. It is designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The lead is implanted into the heart and connected to a pacemaker, which can be programmed to meet the specific needs of the patient. This device is crucial in managing various types of arrhythmias, particularly in patients with bradycardia.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with symptomatic bradycardia or heart block. It is typically used in hospital settings, including operating rooms and cardiac catheterization labs. The device is primarily utilized by cardiologists and electrophysiologists who specialize in heart rhythm disorders. It is suitable for adult patients who require long-term pacing support.
Indications for Use
The FDA indications for this device include use in patients who require cardiac pacing due to arrhythmias such as bradycardia or heart block. It is intended for individuals who need assistance in maintaining a regular heart rhythm.
Practical Considerations
The Model 431-06 Polyflex Implantable Pacing Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper implantation technique is crucial to ensure optimal performance and longevity of the device.
Frequently Asked Questions
What is Model 431-06 Polyflex Implantable Pacing Lead used for?
It is used to deliver electrical impulses to the heart to manage arrhythmias, particularly in patients with bradycardia.
What specialties typically use this device?
This device is typically used by cardiologists and electrophysiologists.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias 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.