BCI Atlas

The applicant of record on the FDA's VNS Therapy System approval, the vagus nerve stimulator first approved for epilepsy in 1997 under Cyberonics.

Company — American

LivaNova

Official site → Houston, TX, USA

company · vagus nerve stimulation · VNS · neuromodulation · FDA · LivaNova

Last reviewed against public sources: Oct 6, 2026

LivaNova USA, Inc. is the applicant listed on the FDA premarket approval record for the VNS Therapy System, P970003, at 100 Cyberonics Blvd, Houston, Texas. The same approval documents list the earlier applicant as Cyberonics, Inc.

FDA record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970003
Company site: https://www.livanova.com/

Regulatory trail (FDA records)

16 July 1997: approval for epilepsy.
15 July 2005: notice of approval for treatment-resistant depression (supplement S50).

Device entries

Vagus nerve stimulation (FDA record)

Limits

The FDA record does not say when or how Cyberonics became LivaNova, so this brief does not state it.