Livanova Usa Inc

FDA Filings

This page includes the latest FDA filings for Livanova Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Livanova Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

Celeste Kreul

FDA Registration(s)

Registration Number	1644487
FEI Number	1000117004
Name	LivaNova USA, Inc.
Owner & Operator	LivaNova USA, Inc.
Contact Address	100 CYBERONICS BLVD. -- Houston TX 77058 US
Official Correspondent	Deborah Castillo x-800-3321375-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	100 CYBERONICS BLVD. HOUSTON, TX 77058 US
Establishment Type	Manufacture Medical Device

Registration Number	1718850
FEI Number	1718850
Name	LivaNova USA, INC.
Owner & Operator	LivaNova USA, Inc.
Contact Address	14401 West 65th Way -- Arvada CO 80004 US
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	14401 WEST 65TH WAY ARVADA, CO 80004 US
Establishment Type	Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 10803622156608 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 10803622156592 LIVANOVA USA, INC.	Cardioplegia Pack	2024-04-23
GUDID 10803622156561 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 10803622156554 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 10803622156516 LIVANOVA USA, INC.	Cardioplegia Pack	2024-04-23
GUDID 10803622156509 LIVANOVA USA, INC.	Cardioplegia Pack	2024-04-23
GUDID 00803622156632 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 00803622156625 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 00803622156540 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 00803622156533 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 00803622156526 LIVANOVA USA, INC.	Perfusion Pack	2024-04-23
GUDID 10803622156486 LIVANOVA USA, INC.	Perfusion Pack	2024-04-17
GUDID 10803622156455 LIVANOVA USA, INC.	Perfusion Pack	2024-04-17
GUDID 10803622156448 LIVANOVA USA, INC.	Perfusion Pack	2024-04-17
GUDID 10803622156394 LIVANOVA USA, INC.	Perfusion Pack	2024-04-17
GUDID 00803622156496 LIVANOVA USA, INC.	Perfusion Pack	2024-04-17
GUDID 00803622156472 LIVANOVA USA, INC.	Perfusion Pack	2024-04-17
GUDID 10803622156462 LIVANOVA USA, INC.	Perfusion Pack	2024-04-12
GUDID 10803622156431 LIVANOVA USA, INC.	Perfusion Pack	2024-04-12
GUDID 10803622156424 LIVANOVA USA, INC.	Perfusion Pack	2024-04-12
GUDID 00803622156588 LIVANOVA USA, INC.	Perfusion Pack	2024-04-12
GUDID 00803622156571 LIVANOVA USA, INC.	Perfusion Pack	2024-04-12
GUDID 10803622156417 LIVANOVA USA, INC.	Cardioplegia Pack	2024-04-05
GUDID 10803622156387 LIVANOVA USA, INC.	Cardioplegia Pack	2024-04-05
GUDID 10803622156370 LIVANOVA USA, INC.	Perfusion Pack	2024-04-05
GUDID 00803622156403 LIVANOVA USA, INC.	Perfusion Pack	2024-04-05
GUDID 00803622156366 LIVANOVA USA, INC.	Perfusion Pack	2024-04-05
GUDID 00803622156359 LIVANOVA USA, INC.	Perfusion Pack	2024-04-01
GUDID 00803622156335 LIVANOVA USA, INC.	Perfusion Pack	2024-04-01
GUDID 00803622156328 LIVANOVA USA, INC.	Perfusion Pack	2024-04-01
GUDID 00803622156311 LIVANOVA USA, INC.	Perfusion Pack	2024-04-01
GUDID 00803622156168 LIVANOVA USA, INC.	Perfusion Pack	2024-04-01
GUDID 10803622156349 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 10803622156264 LIVANOVA USA, INC.	Cardioplegia Pack	2024-03-26
GUDID 10803622156240 LIVANOVA USA, INC.	Cardioplegia Pack	2024-03-26
GUDID 10803622156233 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 10803622156219 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 10803622156202 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 00803622156304 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 00803622156281 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 00803622156199 LIVANOVA USA, INC.	Perfusion Pack	2024-03-26
GUDID 10803622156110 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156274 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156250 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156182 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156175 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156144 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156090 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156076 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156069 LIVANOVA USA, INC.	Perfusion Pack	2024-03-18
GUDID 00803622156151 LIVANOVA USA, INC.	Perfusion Pack	2024-03-14
GUDID 10803622156226 LIVANOVA USA, INC.	Cardioplegia Pack	2024-03-12
GUDID 10803622156011 LIVANOVA USA, INC.	Perfusion Pack	2024-03-11
GUDID 10803622156004 LIVANOVA USA, INC.	Perfusion Pack	2024-03-11
GUDID 00803622156137 LIVANOVA USA, INC.	Perfusion Pack	2024-03-11
GUDID 00803622156045 LIVANOVA USA, INC.	Perfusion Pack	2024-03-11
GUDID 00803622156038 LIVANOVA USA, INC.	Perfusion Pack	2024-03-11
GUDID 10803622156028 LIVANOVA USA, INC.	Perfusion Pack	2024-03-07
GUDID 00803622156052 LIVANOVA USA, INC.	Perfusion Pack	2024-03-07
GUDID 00803622155994 LIVANOVA USA, INC.	Perfusion Pack	2024-03-07
GUDID 00803622155963 LIVANOVA USA, INC.	Perfusion Pack	2024-03-04
GUDID 00803622155956 LIVANOVA USA, INC.	Perfusion Pack	2024-03-04
GUDID 00803622155925 LIVANOVA USA, INC.	Perfusion Pack	2024-03-04
GUDID 00803622155918 LIVANOVA USA, INC.	Perfusion Pack	2024-03-04
GUDID 00803622155895 LIVANOVA USA, INC.	Perfusion Pack	2024-03-04
GUDID 10803622155946 LIVANOVA USA, INC.	Perfusion Pack	2024-02-26
GUDID 10803622155939 LIVANOVA USA, INC.	Perfusion Pack	2024-02-23
GUDID 10803622155885 LIVANOVA USA, INC.	Perfusion Pack	2024-02-22
GUDID 10803622155861 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 10803622155748 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 10803622155731 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155901 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155871 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155765 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155758 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155703 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155673 LIVANOVA USA, INC.	Perfusion Pack	2024-02-19
GUDID 00803622155826 LIVANOVA USA, INC.	Perfusion Pack	2024-02-14
GUDID 00803622155819 LIVANOVA USA, INC.	Perfusion Pack	2024-02-14
GUDID 00803622155796 LIVANOVA USA, INC.	Perfusion Pack	2024-02-14
GUDID 10803622155854 LIVANOVA USA, INC.	Perfusion Pack	2024-02-13
GUDID 10803622155847 LIVANOVA USA, INC.	Cardioplegia Pack	2024-02-13
GUDID 00803622155833 LIVANOVA USA, INC.	Perfusion Pack	2024-02-13
GUDID 00803622155802 LIVANOVA USA, INC.	Perfusion Pack	2024-02-13
GUDID 00803622155789 LIVANOVA USA, INC.	Perfusion Pack	2024-02-08
GUDID 00803622155499 LIVANOVA USA, INC.	Perfusion Pack	2024-02-08
GUDID 00803622155772 LIVANOVA USA, INC.	Perfusion Pack	2024-02-06
GUDID 00803622155727 LIVANOVA USA, INC.	Perfusion Pack	2024-02-06
GUDID 00803622155710 LIVANOVA USA, INC.	Perfusion Pack	2024-02-06
GUDID 00803622155697 LIVANOVA USA, INC.	Perfusion Pack	2024-02-06
GUDID 00803622155680 LIVANOVA USA, INC.	Perfusion Pack	2024-02-06
GUDID 00803622155659 LIVANOVA USA, INC.	Perfusion Pack	2024-02-06
GUDID 10803622155601 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155642 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155635 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155628 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155611 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155598 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155574 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
GUDID 00803622155567 LIVANOVA USA, INC.	Perfusion Pack	2024-02-01
PMA P970003S234 LivaNova USA, Inc.	VNS Therapy System	2021-02-22
PMA P970003S232 LivaNova USA, Inc.	VNS Therapy System	2020-03-26
PMA P970003S230 LivaNova USA, Inc.	VNS Therapy System	2020-01-29
PMA P970003S229 LivaNova USA, Inc.	VNS Therapy System	2020-01-13
PMA P970003S227 LivaNova USA, Inc.	VNS Therapy System	2019-10-24
PMA P970003S226 LivaNova USA, Inc.	VNS Therapy System	2019-09-05
PMA P970003S224 LivaNova USA, Inc.	VNS Therapy System	2019-05-22
PMA P970003S221 LivaNova USA, Inc.	SenTiva Model 1000 Generator	2019-03-27
PMA P970003S223 LivaNova USA, Inc.	VNS Therapy System	2019-03-12
PMA P970003S222 LivaNova USA, Inc.	VNS Therapy System	2019-02-14
PMA P970003S219 LivaNova USA, Inc.	VNS Therapy System	2019-02-01
PMA P970003S218 LivaNova USA, Inc.	VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer	2018-07-27
PMA P970003S215 LivaNova USA, Inc.	VNS Therapy System	2018-02-14
PMA P970003S216 LivaNova USA, Inc.	VNS Therapy System	2018-01-24
PMA P970003S214 LivaNova USA, Inc.	VNS Therapy System	2017-12-27
PMA P970003S211 LivaNova USA, Inc.	VNS Therapy Model 3000 Programmer	2017-10-03
PMA P970003S210 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2017-10-03
PMA P970003S213 LivaNova USA, Inc.	VNS Therapy System	2017-08-11
PMA P970003S207 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2017-06-23
PMA P970003S205 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2017-06-06
PMA P970003S198 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2017-04-28
PMA P970003S209 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2017-02-16
PMA P970003S208 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2017-01-18
PMA P970003S206 LivaNova USA, Inc.	NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator	2016-12-06
PMA P970003S200 LivaNova USA, Inc.	DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.	2016-11-23
PMA P970003S195 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-11-23
PMA P970003S204 LivaNova USA, Inc.	ASPIRESR MODEL 106 GENERATOR	2016-09-09
PMA P970003S203 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-08-12
PMA P970003S202 LivaNova USA, Inc.	VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD	2016-08-12
PMA P970003S201 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-07-29
PMA P970003S197 LivaNova USA, Inc.	Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.	2016-07-28
PMA P970003S196 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-07-13
PMA P970003S199 LivaNova USA, Inc.	PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR.	2016-06-08
PMA P970003S190 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-04-29
PMA P970003S194 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-03-24
PMA P970003S193 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-03-24
PMA P970003S192 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-03-23
PMA P970003S191 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-03-18
PMA P970003S189 LivaNova USA, Inc.	VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE	2016-02-26
PMA P970003S188 LivaNova USA, Inc.	PULSE/PULSE DUO GENERATOR-MODEL 102/102R	2016-02-19
PMA P970003S170 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2016-02-12
PMA P970003S182 LivaNova USA, Inc.	ASPIRESR GENERATOR -MODEL 106	2015-12-18
PMA P970003S187 LivaNova USA, Inc.	VNS THERAPY MODEL 303 LEAD	2015-11-25
PMA P970003S186 LivaNova USA, Inc.	VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER	2015-11-20
PMA P970003S183 LivaNova USA, Inc.	VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)	2015-10-28
PMA P970003S185 LivaNova USA, Inc.	PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR	2015-09-30
PMA P970003S184 LivaNova USA, Inc.	VNS THERAPY MODEL 302 LEAD	2015-08-28
PMA P970003S179 LivaNova USA, Inc.	PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R	2015-08-21
PMA P970003S181 LivaNova USA, Inc.	CYBERONICS VNS THERAPY SYSTEM	2015-07-31
PMA P970003S180 LivaNova USA, Inc.	DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR	2015-07-08
PMA P970003S174 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2015-06-04
PMA P970003S173 LivaNova USA, Inc.	VNS THERAPY ASPIRESR	2015-05-29
PMA P970003S178 LivaNova USA, Inc.	DEMIPULSE MODEL 103 GENERATOR	2015-04-22
PMA P970003S177 LivaNova USA, Inc.	VNS THERAPY SYSTEM PROGRAMMING SOFTWARE	2015-04-10
PMA P970003S176 LivaNova USA, Inc.	PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105	2015-03-04
DWF LivaNova USA, INC.	Coronary Artery Perfusion Cannula	2015-02-12
PMA P970003S175 LivaNova USA, Inc.	VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO	2014-12-17
PMN K993818 \| DWF LivaNova USA, INC.	Pressure Monitoring Line	2014-11-06
PMN K993818 \| DWF LivaNova USA, INC.	Perfusion Adapter	2014-11-06
PMN K981601 \| DWF LivaNova USA, INC.	Vent Catheter	2014-11-06
PMN K972503 \| DWF LivaNova USA, INC.	Vessel Cannula	2014-11-06
PMN K972503 \| DWF LivaNova USA, INC.	Perfusion Adapter	2014-11-06
PMN K972503 \| DWF LivaNova USA, INC.	Aortic Root Cannula	2014-11-06
PMN K972503 \| DWF LivaNova USA, INC.	Air Aspirator	2014-11-06
PMN K943934 \| DWF LivaNova USA, INC.	Venous Return Cannula	2014-11-06
PMN K943934 \| DWF LivaNova USA, INC.	Tri Stage Venous Return Cannula	2014-11-06
PMN K943934 \| DWF LivaNova USA, INC.	Dual Stage Venous Return Cannula	2014-11-06
PMN K943934 \| DWF LivaNova USA, INC.	Aortic Arch Cannula	2014-11-06
PMN K854640 \| DWF LivaNova USA, INC.	SCCA	2014-11-06
PMN K854640 \| DWF LivaNova USA, INC.	Cardioplegia Adapter	2014-11-06
PMN K030231 \| DWF LivaNova USA, INC.	Coronary Artery Perfusion Cannula	2014-11-06
PMN K010974 \| DWF LivaNova USA, INC.	Retrograde Cardioplega Cannula	2014-11-06
PMN K002019 \| DWF LivaNova USA, INC.	Retrograde Cardioplegia Cannula	2014-11-06
PMN K000830 \| DWF LivaNova USA, INC.	Cannulation Tourniquet	2014-11-06
GBS LivaNova USA, INC.	Thoracic Catheter	2014-11-06
GAE LivaNova USA, INC.	Vasco Loop	2014-11-06
FQH LivaNova USA, INC.	Mister	2014-11-06
PMN K982891 \| DTS LivaNova USA, INC.	Suction Wand	2014-08-27
PMN K982891 \| DTS LivaNova USA, INC.	Suction Sump	2014-08-27
PMA P970003S172 LivaNova USA, Inc.	VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304	2014-07-17
PMA P970003S169 LivaNova USA, Inc.	VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)	2014-07-02
PMA P970003S166 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2014-05-09
PMA P970003S168 LivaNova USA, Inc.	CYBERONICS VNS THERAPY SYSTEM	2014-03-28
PMA P970003S167 LivaNova USA, Inc.	MODEL 201 PROGRAMMING WAND	2014-01-02
PMA P970003S146 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2013-11-26
PMA P970003S164 LivaNova USA, Inc.	VNS THERAPY ACCESSORY PACK	2013-09-23
PMA P970003S165 LivaNova USA, Inc.	DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR	2013-09-05
PMA P970003S162 LivaNova USA, Inc.	VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)	2013-07-10
PMN K122735 \| GCJ LivaNova USA, INC.	VascuLoop	2013-05-24
PMN K122735 \| GAT LivaNova USA, INC.	VascuLoop	2013-05-24
PMA P970003S163 LivaNova USA, Inc.	VNS THERAPY GENERATOR(PULSE AND PULSE DUO) (ASPIREHC)	2013-05-21
PMA P970003S161 LivaNova USA, Inc.	VNS THERAPY SYSTEM LEADS	2013-05-03
PMA P970003S158 LivaNova USA, Inc.	VNS THERAPY ACCESSORY PACK	2013-05-02
PMA P970003S160 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2013-04-12
PMA P970003S159 LivaNova USA, Inc.	PULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR	2013-04-03
PMA P970003S157 LivaNova USA, Inc.	PERENNIADURA MODEL 303 LEAD	2013-04-03
PMA P970003S155 LivaNova USA, Inc.	VNS THERAPY PULSE/PULSE DUO GENERATOR	2013-02-25
PMN K091542 \| DWF LivaNova USA, INC.	EasyFlow Duo Cannula	2013-02-18
PMN K070749 \| DRE LivaNova USA, INC.	Vascular Dilator Kit	2013-02-18
PMN K060101 \| DWF LivaNova USA, INC.	EasyFlow Aortic Cannula	2013-02-18
PMN K052081 \| DWF LivaNova USA, INC.	RAP Femoral Venous Cannula	2013-02-18
PMN K052081 \| DWF LivaNova USA, INC.	FlexFlow Venous Cannula	2013-02-18
PMA P970003S156 LivaNova USA, Inc.	VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO)	2013-02-07
PMA P970003S154 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2013-02-01
PMA P970003S153 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-10-30
PMA P970003S152 LivaNova USA, Inc.	VNS THERAPY PULSE GENERATOR, 102/102R	2012-09-13
PMA P970003S151 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-09-06
PMA P970003S150 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-07-26
PMA P970003S148 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-07-23
PMA P970003S149 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-06-20
PMA P970003S147 LivaNova USA, Inc.	VNS THERAPY SYSTEM GENERATORS	2012-04-13
PMA P970003S145 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-02-06
PMA P970003S144 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-02-01
PMA P970003S143 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2012-01-18
PMA P970003S142 LivaNova USA, Inc.	VNS THERAPY SYSTEM PULSE GENERATORS	2011-12-23
PMA P970003S140 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-12-20
PMA P970003S141 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-12-02
PMA P970003S139 LivaNova USA, Inc.	VNS THERAPY SYSTEM PULSE GENERATORS	2011-11-09
PMA P970003S135 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-10-31
PMA P970003S138 LivaNova USA, Inc.	VNS THERAPY GENERATORS, LEADS PROGRAMING SOFTWARE, PROGRAMMING WAND AND ASSCCESORY PACK	2011-10-27
PMA P970003S137 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-10-21
PMA P970003S136 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-10-18
PMA P970003S065 LivaNova USA, Inc.	CYBERONICS VNS THERAPY	2011-10-17
PMA P970003S134 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-09-09
PMA P970003S133 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-08-31
PMA P970003S117 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-08-26
PMA P970003S131 LivaNova USA, Inc.	VNS THERAPY SYSTEM	2011-08-11
PMN K940936 \| GEI LivaNova USA, INC.	Endoscopic Monopolar Instrument	2011-08-11
PMN K912019 \| CAC LivaNova USA, INC.	Orthofuser Wound Drainage/Autotransfusion System	2011-01-24
PMN K882414 \| DTN LivaNova USA, INC.	VRECMO Reservoir	2011-01-24
PMN K833322 \| DTL LivaNova USA, INC.	EC Series Connectors	2011-01-24
PMN K102983 \| GEI LivaNova USA, INC.	VascuClear Precision Bipolar	2010-12-20
PMN K092364 \| DTG LivaNova USA, Inc.	Model 7220, Patient Magnet	2009-11-04
PMN K092364 \| DTG LivaNova USA, Inc.	Model 220, Patient Magnet	2009-11-04
PMN K973139 \| GCJ LivaNova USA, INC.	VascuClear Ultra Retractors	2009-05-01
PMN K955120 \| GCM LivaNova USA, INC.	VascuClear Vessel Dissector	2009-05-01
PMN K955120 \| GCM LivaNova USA, INC.	VascuClear Optical Vessel Dissector	2009-05-01
PMN K955120 \| GCM LivaNova USA, INC.	VascuClear EVH	2009-05-01
PMN K962070 \| FLL LivaNova USA, INC.	Temperature Probe	2007-12-18
PMN K920312 \| DTN LivaNova USA, INC.	Perfusion Pack	2007-12-18
PMN K920312 \| DTN LivaNova USA, INC.	Cardoplegia Pack	2007-12-18
PMN K920312 \| DTN LivaNova USA, INC.	Cardioplegia System	2007-12-18
PMN K900753 \| DWF LivaNova USA, INC.	Vein Irrigation Cannula	2007-12-18
PMN K800717 \| DTR LivaNova USA, INC.	Topical Cooling Device	2007-12-18
PMN K800717 \| DTR LivaNova USA, INC.	TCD	2007-12-18
PMN K792134 \| DWP LivaNova USA, INC.	Boncheck Vein Distention System	2007-12-18
PMN K792134 \| DWP LivaNova USA, INC.	BSVD	2007-12-18
PMN K781990 \| DWF LivaNova USA, INC.	Cardiac Insulation Pads	2007-12-18
DTL LivaNova USA, INC.	Perfusion Packs	2007-12-18
PMN K991986 \| CAC LivaNova USA, INC.	BRAT2 System and Accessories	2007-12-13
PMN K981613 \| DWE LivaNova USA, INC.	Tubing	2007-12-13
PMN K981613 \| DWE LivaNova USA, INC.	SMARxT	2007-12-13
PMN K981613 \| DWE LivaNova USA, INC.	Perfusion Packs	2007-12-13
PMN K981613 \| DWE LivaNova USA, INC.	Connectors	2007-12-13
PMN K881330 \| DWF LivaNova USA, INC.	Tubing	2007-12-13
PMN K881330 \| DWF LivaNova USA, INC.	Perfusion Tubing	2007-12-13
PMN K881330 \| DWF LivaNova USA, INC.	Perfusion Pack	2007-12-13
PMN K881330 \| DWF LivaNova USA, INC.	Cardioplegia Pack	2007-12-13
HAO LivaNova USA, Inc.	VNS THERAPY MODEL 402 TUNNELER	2007-06-14
PMN K982406 \| MJJ LivaNova USA, INC.	Vacuum Relief Check Valve	2006-04-25
PMN P970003 \| MUZ LivaNova USA, Inc.	VAGUS NERVE STIMULATOR (VNS) SYSTEM	2005-11-15
PMN P970003 \| LYJ LivaNova USA, Inc.	VAGUS NERVE STIMULATOR (VNS) SYSTEM	2005-11-15
KRI LivaNova USA, INC.	Oxygen Filter	2001-02-01
KRI LivaNova USA, INC.	Holders	2001-02-01
KRI LivaNova USA, INC.	Fittings	2001-02-01
KRI LivaNova USA, INC.	Clamps	2001-02-01
KRI LivaNova USA, INC.	Brackets	2001-02-01

Similar & Related FDA Registered Companies

LivaNova USA, Inc.100 Cyberonics Blvd.houston, TX 77058 PMA NumberP970003 Supplement NumberS237 Date Received12/19/2022 Decision Date01/18/2023 Product Codes LYJ MUZ Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
LivaNova USA, Inc.100 Cyberonics Blvd.houston, TX 77058 PMA NumberP970003 Supplement NumberS236 Date Received04/11/2022 Decision Date06/06/2022 Product Codes LYJ MUZ Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
LivaNova USA, Inc.100 Cyberonics Blvd.houston, TX 77058 PMA NumberP970003 Supplement NumberS235 Date Received02/22/2022 Decision Date03/09/2022 Product Codes MUZ LYJ Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	1G7P9	LIVANOVA USA, INC.
CAGE Code	1G7P9	LIVANOVA USA, INC.
S.A.M. Registration	1G7P9 [194568978]	LIVANOVA USA, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020030411960	Genova,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020030411960	Genova,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020021743506	Genova,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020021743506	Genova,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020021134162	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020021134162	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020021164991	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020021164991	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020020122244	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020020122244	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020012932264	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020012932264	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020012137181	La Spezia,Italy -> New York, New York	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020012137181	La Spezia,Italy -> New York, New York	MEDICAL EQUIPMENT HTS 90189084	50 PKG
2020011456876	La Spezia,Italy -> New York, New York	MEDICAL EQUIPMENT HTS 90189050	50 PKG
2020011456876	La Spezia,Italy -> New York, New York	MEDICAL EQUIPMENT HTS 90189084	50 PKG