đź“‹ FDA Reference
Perm Endocardial Unipolar Tined Atrial
Diag
Summary: The perm endocardial unipolar tined atrial device by Diag is used in cardiac pacing. It is typically utilized by cardiologists for patients requiring atrial pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K812270 ↗
Decision Date ?
September 16, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared via the FDA 510k pathway on September 16, 1981. Manufactured by Diag, it is classified as a Class III device under product code DTB.
What It Is
The perm endocardial unipolar tined atrial device is a cardiac pacing lead designed for permanent implantation in the atrium. It features a unipolar configuration with tines that help secure the lead in place. This device is crucial for maintaining heart rhythm in patients with atrial arrhythmias.
FDA-Cleared Indications
- Permanent endocardial atrial pacing in patients requiring atrial stimulation.
- Use as an atrial pacing lead with a compatible pacemaker system.
Clinical Applications
- Implantation in the right atrium during permanent pacemaker placement.
- Atrial pacing for selected disorders of cardiac impulse formation or conduction.
- Connection to a compatible pacemaker generator to provide atrial electrical stimulation.
Practical Considerations
- The lead uses a unipolar configuration and tined fixation to help maintain its position inside the atrium.
- Available lead lengths and dimensions may vary by model and should be selected for the patient's anatomy and the intended generator system.
- Compatibility with the pacemaker generator, connector standard, sensing requirements and pacing settings must be confirmed before implantation.
- MRI safety cannot be determined from the product code alone; this older lead should be treated as not established as MRI-conditional unless the complete implanted system has specific documentation.
- Potential complications include lead dislodgement, failure to capture or sense, abnormal rhythm, infection, vessel or heart injury, thrombosis and the need for revision or replacement.
Frequently Asked Questions
What is the perm endocardial unipolar tined atrial used for?
It is used for permanent atrial pacing in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring atrial pacing due to arrhythmias.
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.