đź“‹ FDA Reference
Dnp 60-b Unipolar Endocardial Lead
Biotronik, Gmbh &
Summary: The dnp 60-b unipolar endocardial lead is a cardiac device used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K901709 ↗
Decision Date ?
May 22, 1990
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The dnp 60-b unipolar endocardial lead was cleared through the FDA 510(k) pathway on May 22, 1990. Manufactured by Biotronik, Gmbh, it is classified as a Class III device.
What It Is
The dnp 60-b unipolar endocardial lead is a component of a pacemaker system, designed to transmit electrical impulses from the pacemaker to the heart muscle. It is implanted within the heart's endocardial surface and is crucial for maintaining heart rhythm in patients with arrhythmias. The lead's unipolar design means it uses a single electrode to deliver pacing signals.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system for endocardial pacing.
- Cardiac pacing for patients with bradycardia or heart block when pacing support is clinically indicated.
Clinical Applications
- Endocardial lead placement as part of permanent pacemaker implantation.
- Delivery of pacing impulses from a compatible pacemaker generator to the heart.
- Pacing support for symptomatic bradycardia.
- Pacing support for heart block or other labeled conduction disorders requiring cardiac pacing.
Practical Considerations
- The lead is unipolar and must be used with a compatible pacemaker generator and system configuration.
- Available lead lengths and implant dimensions should be selected for the patient's anatomy and the intended cardiac chamber.
- Implantation requires venous access, fluoroscopic or other imaging guidance, electrical testing, and secure positioning within the heart.
- The record does not establish MRI safety for this lead; MRI compatibility must be confirmed for the complete implanted pacing system and the specific device labeling.
- Potential complications include lead dislodgment, failure to capture or sense, abnormal electrical measurements, infection, venous injury, perforation, arrhythmia, and the need for revision or replacement.
Frequently Asked Questions
What is dnp 60-b unipolar endocardial lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing 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.