📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use as part of a cardiac pacing system in patients who require pacing for bradycardia or heart block.
- Implantation to deliver electrical stimulation from a pacemaker generator to the heart.
Clinical Applications
- Permanent pacemaker implantation for symptomatic bradycardia.
- Permanent pacing for clinically significant heart block.
- Connection of an implanted pacemaker generator to the heart muscle.
- Long-term cardiac pacing in adult patients when a physician determines that pacemaker therapy is indicated.
Practical Considerations
- The lead is available in different lengths, and the appropriate length depends on patient anatomy and the planned lead position.
- Compatibility must be confirmed with the selected pacemaker generator and the complete pacing system before implantation.
- Implantation requires appropriate lead positioning, electrical testing, and secure connection to the generator.
- MRI safety cannot be assumed for this older lead. The complete implanted system must be evaluated against current manufacturer and institutional MRI guidance.
- Potential complications include lead dislodgement, fracture, insulation damage, infection, bleeding, venous thrombosis, abnormal heart rhythms, and perforation of the heart or blood vessel.
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.