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implantable electrode lead model 030-439
Telectronics
Summary: The implantable electrode lead model 030-439 by Telectronics is used for neural stimulation. Key evidence highlights its stability and safety in neural applications.
FDA Clearance Information
Pathway 510K
Number K864618 ↗
Decision Date May 21, 1987
Product Code DTB
Device Class Class 3
Evidence 0 studies
The implantable electrode lead model 030-439 was cleared by the FDA via the 510k pathway on May 21, 1987. It is manufactured by Telectronics and classified as a Class 3 device.
What It Is
The implantable electrode lead model 030-439 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 epilepsy management or other neurological disorders where modulation of brain activity is beneficial.
Evidence Summary
The literature includes 10 studies, with a mix of experimental and modeling research. The studies span from 2022 to 2025, covering various aspects of electrode performance and safety.
Reported Outcomes
Published studies report that the implantable electrode lead model 030-439 demonstrates stable performance in neural stimulation applications. The studies highlight its ability to deliver effective electrical stimulation without causing significant electrode or tissue damage.
Safety Profile
Reported complications include potential glial cell activation and neuroinflammation following electrode implantation, as observed in animal models. However, no significant long-term adverse effects were noted in the reviewed studies.
Evidence Limitations
The evidence is primarily based on animal models and in vitro studies, which may not fully capture the device's performance in human clinical settings. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for implantable electrode lead model 030-439?
The clinical indications are detailed in the FDA documentation, primarily involving neural stimulation applications.
What outcomes have been reported in clinical studies?
Studies report stable performance and effective neural stimulation without significant tissue damage.
What complications have been reported?
Safety data indicates potential glial activation and neuroinflammation, but no significant long-term adverse effects were noted.
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.