📋 FDA Reference
Biotronik N Bipolar Peb-60 4-n
Biotronik Sales
Summary: The Biotronik N Bipolar PEB-60 4-N is a Class III medical device used in cardiovascular procedures, specifically for intracardiac applications. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K833099 ↗
Decision Date ?
October 20, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Biotronik N Bipolar PEB-60 4-N was cleared through the FDA 510k pathway on October 20, 1983. Manufactured by Biotronik Sales, it is classified as a Class III device.
What It Is
The Biotronik N Bipolar PEB-60 4-N is a bipolar pacing lead used in cardiac procedures. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with arrhythmias. The bipolar design allows for more precise signal delivery and reduced interference, which is critical in managing complex cardiac conditions.
FDA-Cleared Indications
- Use as a bipolar pacing lead with a compatible cardiac pacemaker system.
- Cardiac pacing in patients requiring treatment for inadequate or abnormal heart rates, including bradycardia or heart block.
Clinical Applications
- Permanent cardiac pacing for clinically significant bradycardia.
- Pacing for heart block or other disorders of cardiac electrical conduction.
- Placement and connection of a pacing lead during pacemaker implantation or revision.
- Use by cardiologists or electrophysiologists in cardiac catheterization or electrophysiology laboratory procedures.
Practical Considerations
- The lead must be connected to a compatible pacemaker system and properly secured to reduce the risk of dislodgement.
- Lead placement and electrical testing should be performed with appropriate imaging and pacing-system measurements by trained cardiac specialists.
- MRI safety cannot be determined from the device name or the historical 510(k) record alone; MRI eligibility depends on the complete implanted system and current manufacturer labeling.
- Potential device-related complications include lead dislodgement, failure to sense or capture, abnormal electrical measurements, infection, bleeding, and damage to cardiac or vascular structures.
- The record identifies the model as PEB-60 4-N; clinicians should verify the exact lead length, connector type, and compatibility in the current product documentation before use.
Related Literature
The linked study investigated the efficacy of scar homogenization in VT patients with ischemic cardiomyopathy. It compared outcomes of combined epicardial and endocardial ablation versus endocardial-only ablation over a five-year period. The study found that combined ablation may offer better long-term outcomes, but limitations include its focus on a specific patient group and the need for further research to generalize findings.
Frequently Asked Questions
What is Biotronik N Bipolar PEB-60 4-N 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 commonly use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for use in patients requiring cardiac pacing to manage heart rhythm disorders.
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.