đź“‹ FDA Reference
Label Change Unipolar Endocardial Lead Djp 45-up
Biotronik, Gmbh &
Summary: The Unipolar Endocardial Lead DJP 45-UP is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in cardiac care settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K903927 ↗
Decision Date ?
October 16, 1990
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on October 16, 1990. Manufactured by Biotronik, Gmbh, it is classified as a Class III medical device.
What It Is
The Unipolar Endocardial Lead DJP 45-UP is a type of cardiac lead used in conjunction with pacemakers to deliver electrical impulses directly to the heart muscle. It is designed to be implanted endocardially, meaning it is placed inside the heart chambers. The unipolar design refers to the configuration of the lead, which uses the body as a return path for the electrical circuit, simplifying the lead structure.
FDA-Cleared Indications
- Use with a compatible pacemaker system when cardiac pacing is indicated for bradycardia or another pacing-related arrhythmia.
- Endocardial placement in the heart for delivery of pacing impulses.
Clinical Applications
- Endocardial lead placement during implantation of a permanent pacemaker.
- Cardiac pacing for patients with clinically significant bradycardia.
- Pacing for selected arrhythmias when a compatible unipolar pacemaker system is indicated.
- Connection to a compatible pulse generator as part of a permanent cardiac pacing system.
Practical Considerations
- The unipolar configuration uses the surrounding body tissue as the return path and may not be compatible with every pacemaker pulse generator or programming mode.
- Lead length, diameter, connector configuration and fixation method should be confirmed against the original device labeling and the selected pacemaker system before implantation.
- Placement requires fluoroscopic or other appropriate cardiac imaging guidance, with testing of sensing, pacing threshold and lead impedance before final connection.
- MRI safety cannot be determined from the available FDA record; the lead should be treated as not established for MRI unless the complete implanted system is specifically labeled as MRI-conditional.
- Contraindications and precautions include infection at the access or implant site, inadequate venous access, inability to maintain sterile conditions and a pacemaker system that is not compatible with the lead.
Frequently Asked Questions
What is the Unipolar Endocardial Lead DJP 45-UP used for?
It is used to deliver electrical impulses to the heart in patients requiring pacemaker therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to conditions like bradycardia.
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.