FDA.reportPublic FDA data

VNS Therapy® Symmetry™ Model 8103 Generator

Primary DI
05425025750504
Brand
VNS Therapy® Symmetry™ Model 8103 Generator
Company
LIVANOVA USA, INC.
Model
8103
Device description
Implantable Pulse Generator
Published
2019-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUZStimulator, Autonomic Nerve, Implanted (Depression)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUZStimulator, Autonomic Nerve, Implanted (Depression)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970003226

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970003226VNS THERAPY SYSTEMLivaNova USA, Inc.1997-07-16LYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025750504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025750504054250257505045425025750504

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage 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
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622146947Vascular Dilator Kit200-1202020-08-19
00803622112522Vascular Dilator Kit200-1202014-12-22
00803622164965Perfusion PackPerfusion Pack2026-10-22
00803622164804Perfusion PackPerfusion Pack2026-10-19
00803622164811Perfusion PackPerfusion Pack2026-10-19
00803622164842Perfusion PackPerfusion Pack2026-10-19
00803622164910Perfusion PackPerfusion Pack2026-10-19
00803622164927Perfusion PackPerfusion Pack2026-10-19
00803622164934Perfusion PackPerfusion Pack2026-10-19
00803622164941Perfusion PackPerfusion Pack2026-10-19
00803622164958Perfusion PackPerfusion Pack2026-10-19
00803622164989Perfusion PackPerfusion Pack2026-10-19
00803622164996Perfusion PackPerfusion Pack2026-10-19
00803622165047Perfusion PackPerfusion Pack2026-10-19
00803622165054Perfusion PackPerfusion Pack2026-10-19
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05425025750535VNS Therapy® Programmer, Model 3000 v1.6.2 LIVANOVA USA, INC.MUZ2021-03-01
05425025750528VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorLIVANOVA USA, INC.MUZ2020-07-22
05425025750511Symmetry™ VNS Therapy Kit Model 98142LIVANOVA USA, INC.MUZ2020-03-23
05425025750443VNS Therapy® Programmer, Model 3000 v1.6 LIVANOVA USA, INC.MUZ2019-09-09
05425025750429VNS Therapy® Programmer, Model 3000 v1.5 LIVANOVA USA, INC.MUZ2018-08-01
05425025750481VNS Therapy® Programmer, Model 3000 v1.0.2 LIVANOVA USA, INC.MUZ2018-02-16
05425025750177VNS Therapy® Programming Wand Model 2000LIVANOVA USA, INC.MUZ2017-10-06
05425025750399VNS Therapy® Programmer, Model 3000 v1.0 LIVANOVA USA, INC.MUZ2017-10-06
05425025750405VNS Therapy® SenTiva™ Model 1000 GeneratorLIVANOVA USA, INC.MUZ2017-10-06
05425025750375VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.MUZ2015-10-29
05425025750368VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.MUZ2015-06-02
05425025750382VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.MUZ2015-04-01
05425025750016VNS Therapy® Pulse Model 102 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750023VNS Therapy® Pulse Duo Model 102R GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750030VNS Therapy® Demipulse® Model 103 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750047VNS Therapy® Demipulse Duo® Model 104 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750054VNS Therapy® AspireHC® Model 105 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750092VNS Therapy® Model 302 LeadLIVANOVA USA, INC.MUZ2014-09-17
05425025750108VNS Therapy® Model 302 LeadLIVANOVA USA, INC.MUZ2014-09-17
05425025750115VNS Therapy® PerenniaDURA® Model 303 LeadLIVANOVA USA, INC.MUZ2014-09-17
05425025750122VNS Therapy® PerenniaDURA® Model 303 LeadLIVANOVA USA, INC.MUZ2014-09-17
05425025750139VNS Therapy® PerenniaFLEX® Model 304 LeadLIVANOVA USA, INC.MUZ2014-09-17
05425025750153VNS Therapy® PerenniaFLEX® Model 304 LeadLIVANOVA USA, INC.MUZ2014-09-17
05425025750160NCP® Programming Wand Model 201LIVANOVA USA, INC.MUZ2014-09-17
05425025750184VNS Therapy® Model 250 v8.1 Programming Software (X50)LIVANOVA USA, INC.MUZ2014-09-17
05425025750191VNS Therapy® Model 250 v8.1 Programming Software (X5)LIVANOVA USA, INC.MUZ2014-09-17
05425025750214VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.MUZ2014-09-17
05425025750245VNS Therapy® Model 502 Accessory PackLIVANOVA USA, INC.MUZ2014-09-17