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
510K
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.
Clinical Applications
This lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other arrhythmias requiring electrical pacing. It is utilized in cardiology and electrophysiology departments, typically in hospital settings. The device is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest this device is for patients needing cardiac pacing due to arrhythmias such as bradycardia. It is intended for use in patients who require a reliable and durable lead for their pacemaker systems.
Practical Considerations
When considering this lead, clinicians should note its unipolar configuration, which may affect compatibility with certain pacemaker models. Proper sizing and placement technique are crucial to ensure optimal performance and longevity of the device.
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.