VNS Therapy® SenTiva™ Model 1000 Generator
GUDID 05425025750405
Implantable Pulse Generator
LIVANOVA USA, INC.
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system| Primary Device ID | 05425025750405 |
| NIH Device Record Key | ab1cbe52-f322-4998-8d30-15d39f72106f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VNS Therapy® SenTiva™ Model 1000 Generator |
| Version Model Number | 1000 |
| Company DUNS | 194568978 |
| Company Name | LIVANOVA USA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1 (866) 882-8804 |
| ClinicalTechnicalServices@livanova.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05425025750405 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970003
FDA Product Code
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2017-10-06 |
Devices Manufactured by LIVANOVA USA, INC.
| 10803622158367 - Cardioplegia Pack | 2025-01-31 |
| 00803622152696 - Perfusion Pack | 2024-12-23 |
| 00803622158223 - Perfusion Pack | 2024-12-23 |
| 00803622158247 - Perfusion Pack | 2024-12-23 |
| 10803622158190 - Perfusion Pack | 2024-12-11 |
| 10803622158053 - Perfusion Pack | 2024-11-29 |
| 00803622158131 - Perfusion Pack | 2024-11-29 |
| 10803622158145 - Perfusion Pack | 2024-11-29 |
Trademark Results [VNS Therapy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VNS THERAPY 78939216 3607760 Live/Registered |
LIVANOVA USA, INC. 2006-07-27 |
 VNS THERAPY 78939212 3607759 Dead/Cancelled |
LIVANOVA USA, INC. 2006-07-27 |
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