📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Chronic cardiac pacing in patients who require permanent pacemaker therapy.
- Pacing support for clinically significant bradycardia or heart block when indicated for an implanted pacemaker system.
Clinical Applications
- Permanent pacemaker implantation for chronic bradycardia.
- Permanent pacing for heart block.
- Placement of a transvenous pacing lead connected to an implanted pacemaker generator.
- Long-term cardiac rhythm support in patients who meet indications for permanent pacing.
Practical Considerations
- The lead is available in different lengths to accommodate patient anatomy and the selected implantation route.
- It must be connected to a compatible pacemaker generator and implanted by clinicians trained in cardiac lead placement.
- The record does not establish MRI compatibility; MRI should not be performed unless the complete implanted system is specifically confirmed to be MR conditional or otherwise cleared for MRI.
- Potential lead-related issues include displacement, fracture, insulation failure, loss of capture, infection, venous thrombosis, and cardiac perforation.
- The lead is typically implanted through venous access and positioned in a cardiac chamber under fluoroscopic imaging, with local anesthesia and sedation or general anesthesia depending on the procedure.
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.