Product code LYJ
- Device name
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P970003S253 | VNS Therapy® System | LivaNova USA, Inc. | 2026-03-04 |
| P970003S252 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2025-12-17 |
| P970003S251 | VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand | LivaNova USA, Inc. | 2025-11-25 |
| P970003S250 | VNS Therapy® System | LivaNova USA, Inc. | 2025-09-12 |
| P970003S248 | VNS Therapy System | LivaNova USA, Inc. | 2025-09-05 |
| P970003S247 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2025-05-02 |
| P970003S246 | VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 | LivaNova USA, Inc. | 2025-03-27 |
| P970003S245 | VNS Therapy System | LivaNova USA, Inc. | 2024-11-14 |
| P970003S244 | SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance | LivaNova USA, Inc. | 2024-07-18 |
| P970003S243 | SenTiva™ Generator, SenTiva Duo™ Generator | LivaNova USA, Inc. | 2024-03-15 |
| P970003S241 | VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand | LivaNova USA, Inc. | 2023-09-15 |
| P970003S240 | VNS Therapy System | LivaNova USA, Inc. | 2023-03-02 |
| P970003S239 | VNS Therapy System | LivaNova USA, Inc. | 2023-03-02 |
| P970003S238 | Demipulse™ Generator; Demipulse Duo™ Generator, AspireSR™ Generator, SenTiva™ Generator; SenTiva Duo™ Generator, Symmetr | LivaNova USA, Inc. | 2023-02-07 |
| P970003S237 | VNS Therapy System | LivaNova USA, Inc. | 2023-01-18 |
| P970003S233 | VNS Therapy System | LivaNova USA, Inc. | 2022-08-12 |
| P970003S236 | SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch | LivaNova USA, Inc. | 2022-06-06 |
| P970003S235 | VNS Therapy PerenniaDURA Model 303 Lead | LivaNova USA, Inc. | 2022-03-09 |
| P970003S234 | VNS Therapy System | LivaNova USA, Inc. | 2021-02-22 |
| P970003S231 | VNS Therapy System | LivaNova USA, Inc. | 2020-05-13 |
| P970003S232 | VNS Therapy System | LivaNova USA, Inc. | 2020-03-26 |
| P970003S225 | VNS Therapy System | LivaNova USA, Inc. | 2020-03-20 |
| P970003S228 | VNS Therapy System | LivaNova USA, Inc. | 2020-01-31 |
| P970003S230 | VNS Therapy System | LivaNova USA, Inc. | 2020-01-29 |
| P970003S229 | VNS Therapy System | LivaNova USA, Inc. | 2020-01-13 |
| P970003S227 | VNS Therapy System | LivaNova USA, Inc. | 2019-10-24 |
| P970003S226 | VNS Therapy System | LivaNova USA, Inc. | 2019-09-05 |
| P970003S224 | VNS Therapy System | LivaNova USA, Inc. | 2019-05-22 |
| P970003S221 | SenTiva Model 1000 Generator | LivaNova USA, Inc. | 2019-03-27 |
| P970003S223 | VNS Therapy System | LivaNova USA, Inc. | 2019-03-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05425025750634 | VNS Therapy™ Programmer, Model 3100 v1.1.0 | LIVANOVA USA, INC. | 2023-09-19 |
| 05425025750535 | VNS Therapy® Programmer, Model 3000 v1.6.2 | LIVANOVA USA, INC. | 2021-03-01 |
| 05425025750528 | VNS Therapy® SenTiva Duo™ Model 1000-D Generator | LIVANOVA USA, INC. | 2020-07-22 |
| 05425025750443 | VNS Therapy® Programmer, Model 3000 v1.6 | LIVANOVA USA, INC. | 2019-09-09 |
| 05425025750429 | VNS Therapy® Programmer, Model 3000 v1.5 | LIVANOVA USA, INC. | 2018-08-01 |
| 05425025750481 | VNS Therapy® Programmer, Model 3000 v1.0.2 | LIVANOVA USA, INC. | 2018-02-16 |
| 05425025750405 | VNS Therapy® SenTiva™ Model 1000 Generator | LIVANOVA USA, INC. | 2017-10-06 |
| 05425025750399 | VNS Therapy® Programmer, Model 3000 v1.0 | LIVANOVA USA, INC. | 2017-10-06 |
| 05425025750177 | VNS Therapy® Programming Wand Model 2000 | LIVANOVA USA, INC. | 2017-10-06 |
| 05425025750375 | VNS Therapy® Model 250 v11.0 Programming Software | LIVANOVA USA, INC. | 2015-10-29 |
| 05425025750061 | VNS Therapy® AspireSR® Model 106 Generator | LIVANOVA USA, INC. | 2015-06-02 |
| 05425025750368 | VNS Therapy® Model 250 v11.0 Programming Software | LIVANOVA USA, INC. | 2015-06-02 |
| 05425025750382 | VNS Therapy® Model 250 v10.0 Programming Software | LIVANOVA USA, INC. | 2015-04-01 |
| 05425025750191 | VNS Therapy® Model 250 v8.1 Programming Software (X5) | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750245 | VNS Therapy® Model 502 Accessory Pack | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750214 | VNS Therapy® Model 250 v10.0 Programming Software | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750016 | VNS Therapy® Pulse Model 102 Generator | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750184 | VNS Therapy® Model 250 v8.1 Programming Software (X50) | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750160 | NCP® Programming Wand Model 201 | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750153 | VNS Therapy® PerenniaFLEX® Model 304 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750139 | VNS Therapy® PerenniaFLEX® Model 304 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750122 | VNS Therapy® PerenniaDURA® Model 303 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750115 | VNS Therapy® PerenniaDURA® Model 303 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750108 | VNS Therapy® Model 302 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750092 | VNS Therapy® Model 302 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750054 | VNS Therapy® AspireHC® Model 105 Generator | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750047 | VNS Therapy® Demipulse Duo® Model 104 Generator | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750030 | VNS Therapy® Demipulse® Model 103 Generator | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750023 | VNS Therapy® Pulse Duo Model 102R Generator | LIVANOVA USA, INC. | 2014-09-17 |