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model 486-05 polyflex r implantable pacing lead
Intermedics
Summary: The Model 486-05 Polyflex R is an implantable pacing lead used in cardiac pacing systems. It is utilized by cardiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K864564 ↗
Decision Date
December 5, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 486-05 Polyflex R Implantable Pacing Lead by Intermedics was cleared through the FDA 510(k) pathway on December 5, 1986. It is a Class III medical device.
What It Is
The Model 486-05 Polyflex R is an implantable pacing lead designed to deliver electrical impulses from a pacemaker to the heart muscle. It is a critical component in cardiac pacing systems, helping to maintain appropriate heart rates in patients with arrhythmias. The lead is made to be flexible and durable, ensuring reliable performance over time.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other heart rhythm disorders. Cardiologists and electrophysiologists typically perform these procedures in hospital settings. The device is suitable for adult patients requiring long-term pacing support.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions like bradycardia, where the heart beats too slowly. It is used to ensure the heart maintains a regular and adequate rhythm.
Practical Considerations
The Model 486-05 Polyflex R is compatible with a range of pacemakers. Clinicians should consider lead length and compatibility with the chosen pacemaker model. Proper implantation technique is crucial to ensure optimal performance and longevity.
Frequently Asked Questions
What is the Model 486-05 Polyflex R Implantable Pacing Lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart, helping to regulate heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia, ensuring the heart maintains a regular rhythm.
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.