Product code MUZ
- Device name
- Stimulator, Autonomic Nerve, Implanted (Depression)
- 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
- Definition
- The device is indicated 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.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P970003S190 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2016-04-29 |
| P970003S189 | VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE | LivaNova USA, Inc. | 2016-02-26 |
| P970003S188 | PULSE/PULSE DUO GENERATOR-MODEL 102/102R | LivaNova USA, Inc. | 2016-02-19 |
| P970003S170 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2016-02-12 |
| P970003S182 | ASPIRESR GENERATOR -MODEL 106 | LivaNova USA, Inc. | 2015-12-18 |
| P970003S187 | VNS THERAPY MODEL 303 LEAD | LivaNova USA, Inc. | 2015-11-25 |
| P970003S186 | VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER | LivaNova USA, Inc. | 2015-11-20 |
| P970003S183 | VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4) | LivaNova USA, Inc. | 2015-10-28 |
| P970003S185 | PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR | LivaNova USA, Inc. | 2015-09-30 |
| P970003S184 | VNS THERAPY MODEL 302 LEAD | LivaNova USA, Inc. | 2015-08-28 |
| P970003S181 | CYBERONICS VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2015-07-31 |
| P970003S180 | DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR | LivaNova USA, Inc. | 2015-07-08 |
| P970003S174 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2015-06-04 |
| P970003S178 | DEMIPULSE MODEL 103 GENERATOR | LivaNova USA, Inc. | 2015-04-22 |
| P970003S177 | VNS THERAPY SYSTEM PROGRAMMING SOFTWARE | LivaNova USA, Inc. | 2015-04-10 |
| P970003S176 | PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105 | LivaNova USA, Inc. | 2015-03-04 |
| P970003S175 | VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO | LivaNova USA, Inc. | 2014-12-17 |
| P970003S172 | VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304 | LivaNova USA, Inc. | 2014-07-17 |
| P970003S169 | VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC) | LivaNova USA, Inc. | 2014-07-02 |
| P970003S166 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2014-05-09 |
| P970003S168 | CYBERONICS VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2014-03-28 |
| P970003S167 | MODEL 201 PROGRAMMING WAND | LivaNova USA, Inc. | 2014-01-02 |
| P970003S146 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2013-11-26 |
| P970003S164 | VNS THERAPY ACCESSORY PACK | LivaNova USA, Inc. | 2013-09-23 |
| P970003S165 | DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR | LivaNova USA, Inc. | 2013-09-05 |
| P970003S162 | VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC) | LivaNova USA, Inc. | 2013-07-10 |
| P970003S163 | VNS THERAPY GENERATOR(PULSE AND PULSE DUO) (ASPIREHC) | LivaNova USA, Inc. | 2013-05-21 |
| P970003S161 | VNS THERAPY SYSTEM LEADS | LivaNova USA, Inc. | 2013-05-03 |
| P970003S158 | VNS THERAPY ACCESSORY PACK | LivaNova USA, Inc. | 2013-05-02 |
| P970003S160 | VNS THERAPY SYSTEM | LivaNova USA, Inc. | 2013-04-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 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 |
| 05425025750511 | Symmetry™ VNS Therapy Kit Model 98142 | LIVANOVA USA, INC. | 2020-03-23 |
| 05425025750443 | VNS Therapy® Programmer, Model 3000 v1.6 | LIVANOVA USA, INC. | 2019-09-09 |
| 05425025750504 | VNS Therapy® Symmetry™ Model 8103 Generator | 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 |
| 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 |
| 05425025750054 | VNS Therapy® AspireHC® Model 105 Generator | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750092 | VNS Therapy® Model 302 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750108 | VNS Therapy® Model 302 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750115 | VNS Therapy® PerenniaDURA® Model 303 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750122 | VNS Therapy® PerenniaDURA® Model 303 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750139 | VNS Therapy® PerenniaFLEX® Model 304 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750153 | VNS Therapy® PerenniaFLEX® Model 304 Lead | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750160 | NCP® Programming Wand Model 201 | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750047 | VNS Therapy® Demipulse Duo® Model 104 Generator | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750184 | VNS Therapy® Model 250 v8.1 Programming Software (X50) | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750191 | VNS Therapy® Model 250 v8.1 Programming Software (X5) | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750214 | VNS Therapy® Model 250 v10.0 Programming Software | LIVANOVA USA, INC. | 2014-09-17 |
| 05425025750245 | VNS Therapy® Model 502 Accessory Pack | 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 |
| 05425025750016 | VNS Therapy® Pulse Model 102 Generator | LIVANOVA USA, INC. | 2014-09-17 |