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model 430-01 biopore implantable pacing lead
Intermedics
Summary: The Model 430-01 Biopore Implantable Pacing Lead is used in cardiac pacing procedures to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K862054 ↗
Decision Date
September 19, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 430-01 Biopore Implantable Pacing Lead was cleared via the FDA 510(k) pathway on September 19, 1986. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 430-01 Biopore Implantable Pacing Lead is a medical device designed to provide electrical stimulation to the heart in patients requiring pacing. It is implanted into the heart muscle and connected to a pacemaker, which regulates heart rhythm. The lead features a biopore design that promotes tissue ingrowth, enhancing stability and reducing the risk of lead dislodgement.
Clinical Applications
This pacing lead is commonly used in procedures to treat bradycardia, where the heart beats too slowly. It is typically utilized in cardiology and electrophysiology departments within hospitals. The device is suitable for a wide range of patients, including those with heart block or sick sinus syndrome, who require long-term pacing support.
Indications for Use
The FDA indications for this device include use in patients who need cardiac pacing due to conditions like bradycardia or heart block. It is intended for individuals who require consistent electrical stimulation to maintain an adequate heart rate.
Practical Considerations
When using the Model 430-01, clinicians should consider the appropriate lead length and diameter for the patient's anatomy. Compatibility with various pacemaker models should be confirmed. Proper implantation technique is crucial to ensure lead stability and function.
Frequently Asked Questions
What is the Model 430-01 Biopore Implantable Pacing Lead used for?
It is used to provide electrical stimulation to the heart in patients who require pacing due to conditions like 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 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.