📋 FDA Reference
Model 431-01 Biopore Implantable Pacing Lead
Intermedics
Summary: The Model 431-01 Biopore Implantable Pacing Lead is a medical device used for cardiac pacing. It is primarily used by cardiologists for patients requiring pacing therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854918 ↗
Decision Date ?
March 11, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 431-01 Biopore Implantable Pacing Lead was cleared through the FDA 510(k) pathway on March 11, 1986. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 431-01 Biopore Implantable Pacing Lead is a device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is implanted into the heart tissue and connected to a pacemaker. The lead features a biopore design that enhances tissue integration and stability within the heart.
FDA-Cleared Indications
- Use as a lead in an implanted cardiac pacing system for patients requiring cardiac pacing.
- Use to deliver pacing impulses to cardiac tissue when connected to a compatible pacemaker.
Clinical Applications
- Implanted cardiac pacing for clinically significant slow heart rhythms.
- Pacing support for patients with heart block or other conditions requiring long-term pacemaker therapy.
- Placement by a cardiologist or electrophysiologist as part of a permanent pacemaker system.
Practical Considerations
- The lead must be implanted and connected to a compatible pacemaker or pulse generator.
- Available lead length and configuration must be selected to match the patient's anatomy and intended cardiac chamber.
- Implantation requires imaging and electrical testing to confirm appropriate position, fixation, sensing and pacing thresholds.
- MRI safety cannot be determined from this record alone; the complete implanted system must be evaluated against current MRI labeling before scanning.
- Potential complications include lead displacement, failure to capture or sense, infection, bleeding, cardiac perforation and venous thrombosis.
Frequently Asked Questions
What is the Model 431-01 Biopore Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block.
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 requiring cardiac pacing due to conditions like slow heart rhythms 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.