📋 FDA Reference
Model 431-02 Biopore Implantable Pacing Lead
Intermedics
Summary: The model 431-02 biopore implantable pacing lead is a cardiac pacing lead used in patients requiring pacemaker therapy. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K862257 ↗
Decision Date ?
July 10, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model 431-02 biopore implantable pacing lead by Intermedics was cleared through the FDA 510(k) pathway on July 10, 1986. It is classified as a Class III device under product code DTB.
What It Is
The model 431-02 biopore implantable pacing lead is a medical device designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper cardiac rhythm. It features a biopore design to enhance tissue ingrowth and stability within the heart. This lead is crucial for patients with arrhythmias who require consistent heart pacing to maintain adequate cardiac output.
FDA-Cleared Indications
- Use with an implantable cardiac pacemaker system when cardiac pacing is indicated.
- Cardiac pacing for symptomatic bradycardia.
- Cardiac pacing for atrioventricular conduction disturbances, including heart block.
Clinical Applications
- Placement during implantation of a permanent pacemaker system.
- Delivery of pacing impulses to the heart muscle in patients with clinically indicated bradycardia.
- Use in patients requiring pacing for atrioventricular block or other approved conduction disturbances.
- Connection between an implanted pacemaker generator and the heart during pacemaker system implantation or lead revision.
Practical Considerations
- The lead is available in different lengths to accommodate patient anatomy and the selected implantation route.
- Compatibility must be confirmed with the pacemaker generator and the specific connector and lead system requirements.
- Implantation requires careful positioning, electrical testing, and secure fixation by clinicians trained in cardiac pacing.
- MRI safety cannot be determined from the device name alone. The lead and connected pacemaker system should be treated as not established as MRI-conditional unless current manufacturer and FDA documentation confirms otherwise.
- Potential complications include lead displacement, loss of capture or sensing, infection, venous thrombosis, cardiac perforation, and the need for revision or removal.
Frequently Asked Questions
What is the model 431-02 biopore implantable pacing lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart muscle in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, particularly in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or atrioventricular 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.