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model 430-05 polyflex implantable pacing lead
Intermedics
Summary: The Model 430-05 Polyflex Implantable Pacing Lead is a cardiac device used for pacing in patients with arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K864287 ↗
Decision Date
November 20, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 430-05 Polyflex Implantable Pacing Lead was cleared by the FDA via the 510(k) pathway on November 20, 1986. Manufactured by Intermedics, it is a Class III medical device.
What It Is
The Model 430-05 Polyflex Implantable Pacing Lead is a flexible lead 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 regulates the heart's electrical activity.
Clinical Applications
This device is commonly used in patients with bradycardia or other arrhythmias requiring pacing. It is typically used in cardiology departments, especially in settings where long-term pacing is necessary. The device is suitable for adult patients who require reliable cardiac pacing to maintain adequate heart function.
Indications for Use
The FDA indications suggest that this device is for patients who need cardiac pacing due to arrhythmias. It is specifically used in those who have conditions like bradycardia, where the heart beats too slowly.
Practical Considerations
The Model 430-05 Polyflex Implantable Pacing Lead is compatible with most pacemakers. It is important to ensure proper sizing and placement during implantation to avoid complications. Clinicians should be familiar with the lead's handling and connection techniques.
Frequently Asked Questions
What is the Model 430-05 Polyflex Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias, particularly bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to arrhythmias, such as 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.