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model 433-01 biopore implantable pacing lead
Intermedics
Summary: The Model 433-01 Biopore Implantable Pacing Lead is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists for patients requiring pacing therapy.
FDA Clearance Information
Pathway
510K
Number
K862259 ↗
Decision Date
July 10, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 433-01 Biopore Implantable Pacing Lead was cleared through the FDA 510k pathway on July 10, 1986, by Intermedics. It is classified as a Class III device under product code DTB.
What It Is
The Model 433-01 Biopore Implantable Pacing Lead is a medical device designed to be implanted in the heart to provide electrical stimulation for pacing. It consists of a flexible lead with a biopore coating that enhances tissue integration and stability. This device is critical for patients with arrhythmias or heart block who require consistent cardiac pacing to maintain adequate heart rhythms.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. It is typically implanted in patients with bradycardia or heart block who need permanent pacemaker therapy. The device is used in hospital settings, often during procedures in the catheterization lab or surgical suites, and is suitable for adult and elderly patients with specific cardiac conditions.
Indications for Use
The FDA indications for this device include use in patients who require chronic cardiac pacing due to conditions like bradycardia or heart block. It is intended for those who need long-term pacing support to maintain normal heart rhythms.
Practical Considerations
The Model 433-01 Biopore Implantable Pacing Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemaker generators. Clinicians should be trained in lead implantation techniques to ensure proper placement and function.
Frequently Asked Questions
What is the Model 433-01 Biopore Implantable Pacing Lead used for?
It is used to provide electrical pacing to the heart in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring chronic cardiac pacing due to conditions 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.