📋 FDA Reference
Permanent Pacing Lead W Polaris Coated TIPS Various Models
Summary: The permanent pacing lead with polaris coated tips by Oscor is used in cardiac pacing procedures to ensure reliable heart rhythm management. It is primarily utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013339 ↗
Decision Date ?
November 8, 2001
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on November 8, 2001. It is manufactured by Oscor and classified as a Class 3 device under product code DTB.
What It Is
The permanent pacing lead is a medical device used in cardiac pacing systems. It features polaris coated tips designed to enhance electrical conductivity and reduce tissue inflammation. The lead is implanted into the heart muscle to deliver electrical impulses that regulate heartbeats, crucial for patients with arrhythmias or heart block.
FDA-Cleared Indications
- Permanent cardiac pacing in patients who require electrical stimulation of the heart.
- Use with an implanted pacemaker system to deliver pacing impulses to the heart.
Clinical Applications
- Initial implantation of a permanent pacemaker system.
- Replacement or revision of a cardiac pacing lead when continued permanent pacing is required.
- Placement of a pacing lead in patients with bradycardia or heart block requiring permanent cardiac pacing.
- Connection to a compatible pacemaker generator as part of a permanent cardiac pacing system.
Practical Considerations
- The device is available in various models and sizes; clinicians select the lead based on patient anatomy, pacing requirements and the intended implantation site.
- The lead must be connected to a compatible pacemaker generator and implanted using appropriate imaging, electrical testing and lead-positioning techniques.
- Potential complications include lead dislodgement, loss of capture, lead fracture or insulation failure, infection, bleeding and cardiac perforation.
- MRI safety depends on the specific lead model and the complete implanted pacing system. The model-specific labeling should be checked before MRI; do not assume the system is MRI-conditional.
- Contraindications, warnings and handling requirements are model-specific and should be reviewed in the current manufacturer labeling.
Frequently Asked Questions
What is the permanent pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring permanent 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.