LivaNova USA, Inc

FDA Filings

This page includes the latest FDA filings for LivaNova USA, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
LivaNova USA, Inc.
VNS Therapy System2020-03-26
LivaNova USA, Inc.
VNS Therapy System2020-01-29
LivaNova USA, Inc.
VNS Therapy System2020-01-13
LivaNova USA, Inc.
VNS Therapy System2019-10-24
LivaNova USA, Inc.
VNS Therapy System2019-09-05
LivaNova USA, Inc.
VNS Therapy System2019-05-22
LivaNova USA, Inc.
SenTiva Model 1000 Generator2019-03-27
LivaNova USA, Inc.
VNS Therapy System2019-03-12
LivaNova USA, Inc.
VNS Therapy System2019-02-14
LivaNova USA, Inc.
VNS Therapy System2019-02-01
LivaNova USA, Inc.
VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer2018-07-27
LivaNova USA, Inc.
VNS Therapy System2018-02-14
LivaNova USA, Inc.
VNS Therapy System2018-01-24
LivaNova USA, Inc.
VNS Therapy System2017-12-27
LivaNova USA, Inc.
VNS Therapy Model 3000 Programmer2017-10-03
LivaNova USA, Inc.
VNS THERAPY SYSTEM2017-10-03
LivaNova USA, Inc.
VNS Therapy System2017-08-11
LivaNova USA, Inc.
VNS THERAPY SYSTEM2017-06-23
LivaNova USA, Inc.
VNS THERAPY SYSTEM2017-06-06
LivaNova USA, Inc.
VNS THERAPY SYSTEM2017-04-28
LivaNova USA, Inc.
VNS THERAPY SYSTEM2017-02-16
LivaNova USA, Inc.
VNS THERAPY SYSTEM2017-01-18
LivaNova USA, Inc.
NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator2016-12-06
LivaNova USA, Inc.
VNS THERAPY SYSTEM2016-11-23
LivaNova USA, Inc.
DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.2016-11-23
LivaNova USA, Inc.
ASPIRESR MODEL 106 GENERATOR2016-09-09
LivaNova USA, Inc.
VNS THERAPY SYSTEM2016-08-12
LivaNova USA, Inc.
VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD2016-08-12
LivaNova USA, Inc.
VNS THERAPY SYSTEM2016-07-29
LivaNova USA, Inc.
Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.2016-07-28

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Perfusion Pack
LIVANOVA USA, INC.2020-04-01
Perfusion Pack
LIVANOVA USA, INC.2020-04-01
Symmetry™ VNS Therapy Kit Model 98142
LIVANOVA USA, INC.2020-03-31
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-26
Perfusion Pack
LIVANOVA USA, INC.2020-03-20
Perfusion Pack
LIVANOVA USA, INC.2020-03-20
Perfusion Pack
LIVANOVA USA, INC.2020-03-18
Perfusion Pack
LIVANOVA USA, INC.2020-03-18
Perfusion Pack
LIVANOVA USA, INC.2020-03-18
Perfusion Pack
LIVANOVA USA, INC.2020-03-18
Perfusion Pack
LIVANOVA USA, INC.2020-03-18
Cardioplegia Pack
LIVANOVA USA, INC.2020-03-18
Perfusion Pack
LIVANOVA USA, INC.2020-03-18
Perfusion Pack
LIVANOVA USA, INC.2020-03-12
Cardioplegia Pack
LIVANOVA USA, INC.2020-03-12
Perfusion Pack
LIVANOVA USA, INC.2020-03-12
Perfusion Pack
LIVANOVA USA, INC.2020-03-12
Perfusion Pack
LIVANOVA USA, INC.2020-03-12
Cardioplegia Pack
LIVANOVA USA, INC.2020-03-12
Perfusion Pack
LIVANOVA USA, INC.2020-03-12
Perfusion Pack
LIVANOVA USA, INC.2020-03-12
VNS Therapy® Symmetry™ Model 8103 Generator
LIVANOVA USA, INC.2020-03-05
VNS Therapy® SenTiva™ Model 1000 Generator
LIVANOVA USA, INC.2020-03-05
VNS Therapy® Model 502 Accessory Pack
LIVANOVA USA, INC.2020-03-05
VNS Therapy® AspireSR® Model 106 Generator
LIVANOVA USA, INC.2020-03-05
VNS Therapy® AspireHC® Model 105 Generator
LIVANOVA USA, INC.2020-03-05
VNS Therapy® Demipulse Duo® Model 104 Generator
LIVANOVA USA, INC.2020-03-05
VNS Therapy® Demipulse® Model 103 Generator
LIVANOVA USA, INC.2020-03-05
VNS Therapy® Pulse Duo Model 102R Generator
LIVANOVA USA, INC.2020-03-05

Related Finance Registrations

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