FDA.reportPublic FDA data

VNS Therapy™ Programmer, Model 3100 v1.1.0

Primary DI
05425025750634
Brand
VNS Therapy™ Programmer, Model 3100 v1.1.0
Company
LIVANOVA USA, INC.
Model
3100
Device description
Programmer and Software
Published
2023-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYJStimulator, Autonomic Nerve, Implanted For Epilepsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYJStimulator, Autonomic Nerve, Implanted For EpilepsyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970003241

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970003241VNS THERAPY SYSTEMLivaNova USA, Inc.1997-07-16LYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025750634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025750634054250257506345425025750634

GMDN Terms#

Term, Definition table
TermDefinition
Vagus nerve electrical stimulation system programmerA device intended to be used to change, noninvasively, one or more of the operating parameters (the programs) of an implanted stimulator used for vagus nerve stimulation (VNS). It is able to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC will then drive the electronics of the wand to communicate with the implanted stimulation system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (866) 882-8804ClinicalTechnicalServices@livanova.com

Regulatory Flags#

DUNS number
194568978
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622163715Perfusion PackPerfusion Pack2026-06-08
00803622163722Perfusion PackPerfusion Pack2026-06-08
00803622163586Perfusion PackPerfusion Pack2026-05-27
00803622163593Perfusion PackPerfusion Pack2026-05-27
00803622163616Perfusion PackPerfusion Pack2026-05-27
00803622163654Perfusion PackPerfusion Pack2026-05-27
00803622163678Perfusion PackPerfusion Pack2026-05-27
00803622163685Perfusion PackPerfusion Pack2026-05-27
00803622163746Perfusion PackPerfusion Pack2026-05-27
00803622163456Perfusion PackPerfusion Pack2026-05-18
00803622163463Perfusion PackPerfusion Pack2026-05-18
00803622163470Perfusion PackPerfusion Pack2026-05-18
00803622163500Perfusion PackPerfusion Pack2026-05-18
00803622163531Perfusion PackPerfusion Pack2026-05-18
00803622163555Perfusion PackPerfusion Pack2026-05-18
00803622163562Perfusion PackPerfusion Pack2026-05-18
00803622163579Perfusion PackPerfusion Pack2026-05-18
00803622163739Perfusion PackPerfusion Pack2026-05-18
00803622128370Tubing OrganizerAX-xxxxx2015-09-22
00803622161506Perfusion PackPerfusion Pack2026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05425025750535VNS Therapy® Programmer, Model 3000 v1.6.2 LIVANOVA USA, INC.LYJ2021-03-01
05425025750528VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorLIVANOVA USA, INC.LYJ2020-07-22
05425025750443VNS Therapy® Programmer, Model 3000 v1.6 LIVANOVA USA, INC.LYJ2019-09-09
05425025750429VNS Therapy® Programmer, Model 3000 v1.5 LIVANOVA USA, INC.LYJ2018-08-01
05425025750481VNS Therapy® Programmer, Model 3000 v1.0.2 LIVANOVA USA, INC.LYJ2018-02-16
05425025750177VNS Therapy® Programming Wand Model 2000LIVANOVA USA, INC.LYJ2017-10-06
05425025750399VNS Therapy® Programmer, Model 3000 v1.0 LIVANOVA USA, INC.LYJ2017-10-06
05425025750405VNS Therapy® SenTiva™ Model 1000 GeneratorLIVANOVA USA, INC.LYJ2017-10-06
05425025750375VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-10-29
05425025750061VNS Therapy® AspireSR® Model 106 GeneratorLIVANOVA USA, INC.LYJ2015-06-02
05425025750368VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-06-02
05425025750382VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-04-01
05425025750016VNS Therapy® Pulse Model 102 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750023VNS Therapy® Pulse Duo Model 102R GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750030VNS Therapy® Demipulse® Model 103 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750047VNS Therapy® Demipulse Duo® Model 104 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750054VNS Therapy® AspireHC® Model 105 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750092VNS Therapy® Model 302 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750108VNS Therapy® Model 302 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750115VNS Therapy® PerenniaDURA® Model 303 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750122VNS Therapy® PerenniaDURA® Model 303 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750139VNS Therapy® PerenniaFLEX® Model 304 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750153VNS Therapy® PerenniaFLEX® Model 304 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750160NCP® Programming Wand Model 201LIVANOVA USA, INC.LYJ2014-09-17
05425025750184VNS Therapy® Model 250 v8.1 Programming Software (X50)LIVANOVA USA, INC.LYJ2014-09-17
05425025750191VNS Therapy® Model 250 v8.1 Programming Software (X5)LIVANOVA USA, INC.LYJ2014-09-17
05425025750214VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.LYJ2014-09-17
05425025750245VNS Therapy® Model 502 Accessory PackLIVANOVA USA, INC.LYJ2014-09-17