Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1644487

FEI Number

1000117004

Entity Name

LivaNova USA, Inc.

City/State/Country

HOUSTON, TX, US

Establishment Address

100 CYBERONICS BLVD., HOUSTON, TX 77058, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

LivaNova USA, Inc. (Owner Number: 9002738)

Owner / Operator Contact Address

100 CYBERONICS BLVD., --, Houston, TX 77058, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092364

PMA Number

N/A

All Registered Proprietary Names

VAGUS NERVE STIMULATOR (VNS) SYSTEM VNS THERAPY MODEL 402 TUNNELER Model 220, Patient Magnet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYJ	Stimulator, Autonomic Nerve, Implanted For Epilepsy	Unknown	Class 3	N/A	2005-11-15
MUZ	Stimulator, Autonomic Nerve, Implanted (Depression)	Unknown	Class 3	N/A	2005-11-15
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2007-06-14
DTG	Magnet, Test, Pacemaker	Cardiovascular	Class 1	870.3690	2009-11-04

Official Correspondent

Bijal Patel-Jain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LivaNova USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233702	LivaNova USA, Inc.	SMARxT Tubing and Connectors	2024-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2012	Cyberonics, Inc	3	VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Z-0006-2012	Cyberonics, Inc	3	Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

Similar Registrations

Registration Number	Establishment Name	Location
3026820968	NEURGAIN TECHNOLOGIES	La Jolla, CA, US
3006247277	OPTICO LTD	LETCHWORTH Hertfordshire, GB
3005621335	DEVEMED GMBH	NEUHAUSEN OB ECK Baden-Wurttemberg, DE
2126670	SCANLAN INTERNATIONAL, INC.	Saint Paul, MN, US
3012833053	PATHWAY MEDTECH, LLC.	Santee, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1644487. Last updated year: 2026. Please use registration number 1644487 when referencing this establishment in official correspondence.