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LivaNova USA, Inc.

240 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VNS THERAPY SYSTEM (P970003/S252)LivaNova USA, Inc.2025-12-17
VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand (P970003/S251)LivaNova USA, Inc.2025-11-25
VNS Therapy® System (P970003/S250)LivaNova USA, Inc.2025-09-12
VNS Therapy System (P970003/S248)LivaNova USA, Inc.2025-09-05
VNS THERAPY SYSTEM (P970003/S247)LivaNova USA, Inc.2025-05-02
VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 (P970003/S246)LivaNova USA, Inc.2025-03-27
VNS Therapy System (P970003/S245)LivaNova USA, Inc.2024-11-14
SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance (P970003/S244)LivaNova USA, Inc.2024-07-18
SenTiva™ Generator, SenTiva Duo™ Generator (P970003/S243)LivaNova USA, Inc.2024-03-15
VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand (P970003/S241)LivaNova USA, Inc.2023-09-15
VNS Therapy System (P970003/S239)LivaNova USA, Inc.2023-03-02
VNS Therapy System (P970003/S240)LivaNova USA, Inc.2023-03-02
Demipulse™ Generator; Demipulse Duo™ Generator, AspireSR™ Generator, SenTiva™ Generator; SenTiva Duo™ Generator, Symmetr (P970003/S238)LivaNova USA, Inc.2023-02-07
VNS Therapy System (P970003/S237)LivaNova USA, Inc.2023-01-18
VNS Therapy System (P970003/S233)LivaNova USA, Inc.2022-08-12
SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch (P970003/S236)LivaNova USA, Inc.2022-06-06
VNS Therapy PerenniaDURA Model 303 Lead (P970003/S235)LivaNova USA, Inc.2022-03-09
VNS Therapy System (P970003/S234)LivaNova USA, Inc.2021-02-22
VNS Therapy System (P970003/S231)LivaNova USA, Inc.2020-05-13
VNS Therapy System (P970003/S232)LivaNova USA, Inc.2020-03-26
VNS Therapy System (P970003/S225)LivaNova USA, Inc.2020-03-20
VNS Therapy System (P970003/S228)LivaNova USA, Inc.2020-01-31
VNS Therapy System (P970003/S230)LivaNova USA, Inc.2020-01-29
VNS Therapy System (P970003/S229)LivaNova USA, Inc.2020-01-13
VNS Therapy System (P970003/S227)LivaNova USA, Inc.2019-10-24
VNS Therapy System (P970003/S226)LivaNova USA, Inc.2019-09-05
VNS Therapy System (P970003/S224)LivaNova USA, Inc.2019-05-22
SenTiva Model 1000 Generator (P970003/S221)LivaNova USA, Inc.2019-03-27
VNS Therapy System (P970003/S223)LivaNova USA, Inc.2019-03-12
VNS Therapy System (P970003/S222)LivaNova USA, Inc.2019-02-14
VNS Therapy System (P970003/S219)LivaNova USA, Inc.2019-02-01
VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer (P970003/S218)LivaNova USA, Inc.2018-07-27
VNS Therapy System (P970003/S215)LivaNova USA, Inc.2018-02-14
VNS Therapy System (P970003/S216)LivaNova USA, Inc.2018-01-24
VNS Therapy System (P970003/S214)LivaNova USA, Inc.2017-12-27
VNS Therapy Model 3000 Programmer (P970003/S211)LivaNova USA, Inc.2017-10-03
VNS THERAPY SYSTEM (P970003/S210)LivaNova USA, Inc.2017-10-03
VNS Therapy System (P970003/S213)LivaNova USA, Inc.2017-08-11
VNS THERAPY SYSTEM (P970003/S207)LivaNova USA, Inc.2017-06-23
VNS THERAPY SYSTEM (P970003/S205)LivaNova USA, Inc.2017-06-06
VNS THERAPY SYSTEM (P970003/S198)LivaNova USA, Inc.2017-04-28
VNS THERAPY SYSTEM (P970003/S209)LivaNova USA, Inc.2017-02-16
VNS THERAPY SYSTEM (P970003/S208)LivaNova USA, Inc.2017-01-18
NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator (P970003/S206)LivaNova USA, Inc.2016-12-06
VNS THERAPY SYSTEM (P970003/S195)LivaNova USA, Inc.2016-11-23
DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR. (P970003/S200)LivaNova USA, Inc.2016-11-23
ASPIRESR MODEL 106 GENERATOR (P970003/S204)LivaNova USA, Inc.2016-09-09
VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD (P970003/S202)LivaNova USA, Inc.2016-08-12
VNS THERAPY SYSTEM (P970003/S203)LivaNova USA, Inc.2016-08-12
VNS THERAPY SYSTEM (P970003/S201)LivaNova USA, Inc.2016-07-29
Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators. (P970003/S197)LivaNova USA, Inc.2016-07-28
VNS THERAPY SYSTEM (P970003/S196)LivaNova USA, Inc.2016-07-13
PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR. (P970003/S199)LivaNova USA, Inc.2016-06-08
VNS THERAPY SYSTEM (P970003/S190)LivaNova USA, Inc.2016-04-29
VNS THERAPY SYSTEM (P970003/S193)LivaNova USA, Inc.2016-03-24
VNS THERAPY SYSTEM (P970003/S194)LivaNova USA, Inc.2016-03-24
VNS THERAPY SYSTEM (P970003/S192)LivaNova USA, Inc.2016-03-23
VNS THERAPY SYSTEM (P970003/S191)LivaNova USA, Inc.2016-03-18
VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE (P970003/S189)LivaNova USA, Inc.2016-02-26
PULSE/PULSE DUO GENERATOR-MODEL 102/102R (P970003/S188)LivaNova USA, Inc.2016-02-19
VNS THERAPY SYSTEM (P970003/S170)LivaNova USA, Inc.2016-02-12
ASPIRESR GENERATOR -MODEL 106 (P970003/S182)LivaNova USA, Inc.2015-12-18
VNS THERAPY MODEL 303 LEAD (P970003/S187)LivaNova USA, Inc.2015-11-25
VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER (P970003/S186)LivaNova USA, Inc.2015-11-20
VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4) (P970003/S183)LivaNova USA, Inc.2015-10-28
PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR (P970003/S185)LivaNova USA, Inc.2015-09-30
VNS THERAPY MODEL 302 LEAD (P970003/S184)LivaNova USA, Inc.2015-08-28
PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R (P970003/S179)LivaNova USA, Inc.2015-08-21
CYBERONICS VNS THERAPY SYSTEM (P970003/S181)LivaNova USA, Inc.2015-07-31
DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR (P970003/S180)LivaNova USA, Inc.2015-07-08
VNS THERAPY SYSTEM (P970003/S174)LivaNova USA, Inc.2015-06-04
VNS THERAPY ASPIRESR (P970003/S173)LivaNova USA, Inc.2015-05-29
DEMIPULSE MODEL 103 GENERATOR (P970003/S178)LivaNova USA, Inc.2015-04-22
VNS THERAPY SYSTEM PROGRAMMING SOFTWARE (P970003/S177)LivaNova USA, Inc.2015-04-10
PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105 (P970003/S176)LivaNova USA, Inc.2015-03-04
VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO (P970003/S175)LivaNova USA, Inc.2014-12-17
VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304 (P970003/S172)LivaNova USA, Inc.2014-07-17
VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC) (P970003/S169)LivaNova USA, Inc.2014-07-02
VNS THERAPY SYSTEM (P970003/S166)LivaNova USA, Inc.2014-05-09
CYBERONICS VNS THERAPY SYSTEM (P970003/S168)LivaNova USA, Inc.2014-03-28
MODEL 201 PROGRAMMING WAND (P970003/S167)LivaNova USA, Inc.2014-01-02
VNS THERAPY SYSTEM (P970003/S146)LivaNova USA, Inc.2013-11-26
VNS THERAPY ACCESSORY PACK (P970003/S164)LivaNova USA, Inc.2013-09-23
DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR (P970003/S165)LivaNova USA, Inc.2013-09-05
VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC) (P970003/S162)LivaNova USA, Inc.2013-07-10
VNS THERAPY GENERATOR(PULSE AND PULSE DUO) (ASPIREHC) (P970003/S163)LivaNova USA, Inc.2013-05-21
VNS THERAPY SYSTEM LEADS (P970003/S161)LivaNova USA, Inc.2013-05-03
VNS THERAPY ACCESSORY PACK (P970003/S158)LivaNova USA, Inc.2013-05-02
VNS THERAPY SYSTEM (P970003/S160)LivaNova USA, Inc.2013-04-12
PERENNIADURA MODEL 303 LEAD (P970003/S157)LivaNova USA, Inc.2013-04-03
PULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR (P970003/S159)LivaNova USA, Inc.2013-04-03
VNS THERAPY PULSE/PULSE DUO GENERATOR (P970003/S155)LivaNova USA, Inc.2013-02-25
VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO) (P970003/S156)LivaNova USA, Inc.2013-02-07
VNS THERAPY SYSTEM (P970003/S154)LivaNova USA, Inc.2013-02-01
VNS THERAPY SYSTEM (P970003/S153)LivaNova USA, Inc.2012-10-30
VNS THERAPY PULSE GENERATOR, 102/102R (P970003/S152)LivaNova USA, Inc.2012-09-13
VNS THERAPY SYSTEM (P970003/S151)LivaNova USA, Inc.2012-09-06
VNS THERAPY SYSTEM (P970003/S150)LivaNova USA, Inc.2012-07-26
VNS THERAPY SYSTEM (P970003/S148)LivaNova USA, Inc.2012-07-23
VNS THERAPY SYSTEM (P970003/S149)LivaNova USA, Inc.2012-06-20
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