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stela model bj44 and bj45 pacing leads
Ela Medical
Summary: The Stela Model BJ44 and BJ45 are pacing leads manufactured by Ela Medical, primarily used in cardiac pacing. Cleared by the FDA via 510k pathway, these devices are supported by 10 studies, though none directly related to the device.
FDA Clearance Information
Pathway
510K
Number
K963738 ↗
Decision Date
May 23, 1997
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Stela Model BJ44 and BJ45 pacing leads were cleared by the FDA through the 510k pathway on May 23, 1997. Manufactured by Ela Medical, these devices are classified as Class 3 under product code DTB.
What It Is
The Stela Model BJ44 and BJ45 are pacing leads designed for use in cardiac pacing systems. These leads are intended to deliver electrical impulses to the heart to maintain an adequate heart rate, particularly in patients with bradycardia.
Clinical Applications
Commonly used in patients requiring cardiac pacing, the Stela pacing leads are utilized in scenarios such as atrioventricular block or sinus node dysfunction. They are integral components of pacemaker systems.
Evidence Summary
The available literature includes 10 studies, though none are directly related to the Stela pacing leads. The studies span various topics and methodologies, including RCTs and retrospective analyses, from 2024 to 2025.
Reported Outcomes
Published studies report no direct outcomes related to the Stela pacing leads. The evidence provided does not include specific efficacy findings for these devices.
Safety Profile
Reported complications include no specific adverse events related to the Stela pacing leads, as the evidence provided does not directly address these devices.
Evidence Limitations
The evidence lacks direct studies on the Stela pacing leads, highlighting a gap in specific clinical outcomes and safety data. Further research is needed to evaluate the efficacy and safety of these devices in clinical practice.
Frequently Asked Questions
What are the clinical indications for Stela Model BJ44 and BJ45 pacing leads?
The clinical indications are not detailed in the provided evidence. Refer to FDA documentation for specific indications.
What outcomes have been reported in clinical studies?
The provided evidence does not report specific outcomes for the Stela pacing leads.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for the Stela pacing leads.
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.