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FDA PMA

Stimulator, autonomic nerve, implanted for epilepsy

PMA Number: P970003 · 2026-10-02

ApplicantLivaNova USA, Inc.
Decision Date2026-10-02
PMA NumberP970003
Product CodeLYJ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

Stimulator, autonomic nerve, implanted for epilepsy is the device name listed in this FDA 510(k) record. The listed applicant is LivaNova USA, Inc.. It received FDA 510(k) clearance on 2026-10-02. The device is classified under product code LYJ. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Stimulator, autonomic nerve, implanted for epilepsy?

Stimulator, autonomic nerve, implanted for epilepsy is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is LivaNova USA, Inc..

When did Stimulator, autonomic nerve, implanted for epilepsy receive FDA 510(k) clearance?

The clearance date for Stimulator, autonomic nerve, implanted for epilepsy can be found in the official FDA records.

Who is the listed applicant for Stimulator, autonomic nerve, implanted for epilepsy?

The FDA 510(k) record lists LivaNova USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimulator, autonomic nerve, implanted for epilepsy?

The FDA product code for Stimulator, autonomic nerve, implanted for epilepsy is LYJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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