📋 FDA Reference
Djp Unipolar
Biotronik Sales
Summary: The DJP Unipolar is a medical device used primarily in cardiovascular procedures. It is utilized by cardiologists and interventional radiologists to manage specific heart conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853567 ↗
Decision Date ?
May 7, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The DJP Unipolar, manufactured by Biotronik Sales, was cleared through the FDA 510(k) pathway on May 7, 1986. It is classified as a Class III device under product code DTB.
What It Is
The DJP Unipolar is a type of cardiac device used in the management of heart rhythm disorders. It operates by delivering electrical impulses to the heart muscle to ensure proper heart rate and rhythm. This device is crucial in treating patients with arrhythmias, providing a reliable solution to maintain cardiac function.
FDA-Cleared Indications
- Cardiac pacing for patients with bradycardia or other rhythm disorders requiring electrical stimulation.
- Use in patients who require cardiac pacing to maintain an adequate heart rate.
Clinical Applications
- Pacing support for symptomatic bradycardia.
- Cardiac pacing for selected heart rhythm disorders requiring electrical stimulation.
- Implantation with a compatible pacing lead in a hospital electrophysiology or cardiology setting.
- Long-term pacing support when determined appropriate by a cardiologist or electrophysiologist.
Practical Considerations
- The device is associated with unipolar cardiac pacing and must be used with a compatible pacing lead and pacing system.
- Implantation requires careful positioning, connection, testing and follow-up by trained cardiac specialists.
- The available record does not provide specific device dimensions, lead compatibility details or MRI-conditional labeling.
- MRI safety should not be assumed; clinicians should verify the complete implanted system and current manufacturer or FDA labeling before MRI.
- Contraindications, precautions and expected service life depend on the complete pacing system, patient condition and current product labeling.
Frequently Asked Questions
What is DJP Unipolar used for?
The DJP Unipolar is used to manage heart rhythm disorders, particularly in patients with bradycardia, by providing electrical pacing to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use the DJP Unipolar in interventional cardiology and electrophysiology settings.
What are the FDA-cleared indications?
The device is indicated for patients with conditions like bradycardia, where it helps maintain an adequate heart rate through electrical stimulation.
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.