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implantable electrode lead model 030-436
Telectronics
Summary: The implantable electrode lead model 030-436 by Telectronics is used for neural stimulation. It is FDA 510k cleared with evidence from 10 studies highlighting its efficacy and safety in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K861767 ↗
Decision Date
July 18, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode lead model 030-436 was cleared via the FDA 510k pathway on July 18, 1986. Manufactured by Telectronics, it is classified as a Class 3 device.
What It Is
The implantable electrode lead model 030-436 is designed for neural stimulation applications. It functions by delivering electrical impulses to targeted neural tissues, aiding in the modulation of neural activity.
Clinical Applications
This device is commonly used in scenarios requiring precise neural stimulation, such as in the treatment of epilepsy or other neurological disorders. It is particularly useful in settings where long-term implantation is necessary.
Evidence Summary
The literature includes 10 studies, comprising various study types, conducted between 2022 and 2025. These studies explore the device's performance, safety, and efficacy in clinical and experimental settings.
Reported Outcomes
Published studies report that the implantable electrode lead model 030-436 effectively delivers neural stimulation with minimal tissue damage. It has shown promise in maintaining stability and functionality over extended periods, as evidenced by in vitro and animal model research.
Safety Profile
Reported complications include potential glial cell activation and neuroinflammation following implantation, as observed in animal models. However, these findings are primarily based on preclinical studies, and further research is needed to confirm these effects in human subjects.
Evidence Limitations
Current evidence is limited by the predominance of preclinical and in vitro studies, with a need for more extensive clinical trials to validate findings in human populations. Additionally, long-term safety and efficacy data are sparse.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead model 030-436?
The device is indicated for neural stimulation applications, particularly in the management of neurological disorders such as epilepsy.
What outcomes have been reported in clinical studies?
Studies report effective neural stimulation with minimal tissue damage and stable performance over time.
What complications have been reported?
Safety data indicate potential glial cell activation and neuroinflammation in preclinical models.
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.