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label change unipolar endocardial lead djp 60-up
Biotronik, Gmbh &
Summary: The Unipolar Endocardial Lead DJP 60-UP is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is typically used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K903929 ↗
Decision Date
October 16, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Unipolar Endocardial Lead DJP 60-UP was cleared through the FDA 510(k) pathway on October 16, 1990. Manufactured by Biotronik, Gmbh &, it is classified as a Class III device.
What It Is
The Unipolar Endocardial Lead DJP 60-UP is a type of cardiac lead used in conjunction with pacemakers to provide electrical stimulation to the heart. It is designed to be implanted endocardially, meaning it is placed inside the heart chambers. The lead is unipolar, which means it uses a single electrode to deliver electrical impulses, typically to the right ventricle. This device is crucial for patients with bradycardia or other conditions that require consistent cardiac pacing.
Clinical Applications
This lead is commonly used in cardiac pacing procedures, particularly in patients with bradyarrhythmias or heart block. It is typically utilized in cardiology and electrophysiology settings, often in hospitals or specialized cardiac care centers. The patient population includes those who require long-term pacing support, such as individuals with sick sinus syndrome or atrioventricular block.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is suitable for individuals who require reliable electrical stimulation of the heart to maintain an adequate heart rate.
Practical Considerations
The Unipolar Endocardial Lead DJP 60-UP is typically available in various lengths to accommodate different patient anatomies. It is important to ensure compatibility with the pacemaker generator being used. Proper implantation technique is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is the Unipolar Endocardial Lead DJP 60-UP used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It 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.