LivaNova USA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1644487	1000117004	LivaNova USA, Inc.	1	N	2026-01-01	100 CYBERONICS BLVD. HOUSTON TX US 77058
1718850	1718850	LivaNova USA, INC.	1	Y	2026-01-01	14401 WEST 65TH WAY ARVADA CO US 80004

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
43820	1913223744	P970003	VNS THERAPY SYSTEM	LYJ	1997-07-16
44497	1094950969	K993818	ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE	DWF	2000-02-08
44497	1278864403	K991986	COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION	CAC	1999-09-09
44497	1794607004	K982891	CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS	DTS	1998-09-30
44497	1989757622	K982406	COBE VACUUM RELIEF CHECK VALVE	MJJ	1998-10-07
44497	1957027934	K981613	COBE SMARXT TUBING AND CONNECTORS	DWE	1998-10-26
44497	1706313106	K973139	ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR	GCJ	1997-11-13
44497	1864684430	K962070	YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE	FLL	1996-07-19
44497	1703440498	K955120	HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR	GCM	1996-01-26
44497	1795960847	K940936	AESCULAP ENDOSCOPIC INSTRUMENTS	GEI	1994-04-19
44497	1232932141	K920312	NEW COBE CARDIOPLEGIA SYSTEM	DTN	1992-10-01
44497	1740794451	K912019	ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM	CAC	1991-10-08
44497	1745885117	K900753	SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)	DWF	1990-04-10
44497	1876286346	K882414	BLOOD RESERVOIR, CARDIOPULMONARY BYPASS	DTN	1988-12-05
44497	1796578973	K881330	COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK	DWF	1988-06-10
44497	1927886227	K854640	MODIFIED CORONARY CARDIOPLEGIA ADAPTOR	DWF	1986-02-10
44497	1388991689	K833322	TUBING CONNECTORS EC-2XXX SERIES	DTL	1983-12-16
44497	1561720112	K800717	TOPICAL COOLING DEV. TCD. #27-999	DTR	1980-04-16
44497	1424387141	K792134	BONCHEK-SHILEY VEIN DISTENTION SYSTEM	DWP	1979-12-04
44497	1237277350	K781990	CARDIAC INSULATION PAD	DWF	1978-12-04
44497	1615788188	K233702	SMARxT Tubing and Connectors	DWE	2024-08-08
44497	1731974843	K122735	SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2	GAT	2013-05-21
44497	1284119403	K102983	VASCUCLEAR PRECISION BIPOLAR	GEI	2010-11-01
43820	1113162512	K092364	MODEL 220 PATIENT MAGNET	DTG	2009-11-03
44497	1485719339	K091542	ESTECH EASYFLOW CANNULA WITH GUIDEWIRE	DWF	2009-10-20
44497	1997348203	K070749	ESTECH PERCUTANEOUS INSERTION DILATOR KIT	DRE	2007-10-24
44497	1732553752	K060101	ESTECH AORTIC EASY FLOW CANNULA	DWF	2006-05-10
44497	1411557485	K052081	REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA	DWF	2005-12-16
44497	1315857376	K030231	CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON	DWF	2003-04-18
44497	1820917614	K000830	CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE	DWF	2000-09-07
43820	1720933748
44497	1011260698
44497	1217198357
44497	1286332762
44497	1309915609
44497	1315857376
44497	1332510001
44497	1359283752
44497	1389317296
44497	1459267014
44497	1466364832
44497	1479435106
44497	1496883459
44497	1547901873
44497	1632376122
44497	1647110416
44497	1664652833
44497	1677156080
44497	1739167902
44497	1789383839
44497	1813465344
44497	1831032230
44497	1877947460
44497	1893558003
44497	1934994769
44497	1974044078
44497	2046731050
44497	2049540959
44497	2073585035

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DWF	10	2009-10-20
DWE	2	2024-08-08
GEI	2	2010-11-01
DTG	2	2009-11-03
CAC	2	1999-09-09
LYJ	2	1997-07-16
DTN	2	1992-10-01
GAT	1	2013-05-21
DRE	1	2007-10-24
MJJ	1	1998-10-07
DTS	1	1998-09-30
GCJ	1	1997-11-13
FLL	1	1996-07-19
GCM	1	1996-01-26
DTL	1	1983-12-16
DTR	1	1980-04-16
DWP	1	1979-12-04

PMA#

VNS Therapy System
2023-01-18
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...
SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch
2022-06-06
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 Des...
VNS Therapy PerenniaDURA Model 303 Lead
2022-03-09
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...
VNS Therapy System
2021-02-22
LivaNova USA, Inc.
VNS Therapy System
2020-03-26
LivaNova USA, Inc.
VNS Therapy System
2020-01-29
LivaNova USA, Inc.
VNS Therapy System
2020-01-13
LivaNova USA, Inc.
VNS Therapy System
2019-10-24
LivaNova USA, Inc.
VNS Therapy System
2019-09-05
LivaNova USA, Inc.
VNS Therapy System
2019-05-22
LivaNova USA, Inc.
SenTiva Model 1000 Generator
2019-03-27
LivaNova USA, Inc.
VNS Therapy System
2019-03-12
LivaNova USA, Inc.
VNS Therapy System
2019-02-14
LivaNova USA, Inc.
VNS Therapy System
2019-02-01
LivaNova USA, Inc.
VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
2018-07-27
LivaNova USA, Inc.
VNS Therapy System
2018-02-14
LivaNova USA, Inc.
VNS Therapy System
2018-01-24
LivaNova USA, Inc.
VNS Therapy System
2017-12-27
LivaNova USA, Inc.
VNS Therapy Model 3000 Programmer
2017-10-03
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2017-10-03
LivaNova USA, Inc.
VNS Therapy System
2017-08-11
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2017-06-23
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2017-06-06
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2017-04-28
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2017-02-16
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2017-01-18
LivaNova USA, Inc.
NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator
2016-12-06
LivaNova USA, Inc.
DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.
2016-11-23
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-11-23
LivaNova USA, Inc.
ASPIRESR MODEL 106 GENERATOR
2016-09-09
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-08-12
LivaNova USA, Inc.
VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD
2016-08-12
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-07-29
LivaNova USA, Inc.
Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.
2016-07-28
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-07-13
LivaNova USA, Inc.
PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR.
2016-06-08
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-04-29
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-03-24
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-03-24
LivaNova USA, Inc.
VNS THERAPY SYSTEM
2016-03-23
LivaNova USA, Inc.

200 records. Showing 1-40. Next

PMN#

RAP Femoral Venous Cannulae
2025-07-10
LivaNova USA, Inc.
SMARxT Tubing and Connectors
2024-08-08
LivaNova USA, Inc.

GUDID#

Perfusion Pack
LIVANOVA USA, INC.
2026-08-25
Perfusion Pack
LIVANOVA USA, INC.
2026-08-25
Perfusion Pack
LIVANOVA USA, INC.
2026-08-25
Perfusion Pack
LIVANOVA USA, INC.
2026-07-30
Perfusion Pack
LIVANOVA USA, INC.
2026-07-17
Perfusion Pack
LIVANOVA USA, INC.
2026-07-17
Perfusion Pack
LIVANOVA USA, INC.
2026-07-17
Perfusion Pack
LIVANOVA USA, INC.
2026-07-10
Perfusion Pack
LIVANOVA USA, INC.
2026-07-10
Perfusion Pack
LIVANOVA USA, INC.
2026-07-10
Perfusion Pack
LIVANOVA USA, INC.
2026-07-10
Perfusion Pack
LIVANOVA USA, INC.
2026-07-10
Cardioplegia Pack
LIVANOVA USA, INC.
2015-04-22
Perfusion Pack
LIVANOVA USA, INC.
2026-07-08
Perfusion Pack
LIVANOVA USA, INC.
2015-04-22
Perfusion Pack
LIVANOVA USA, INC.
2026-06-26
Perfusion Pack
LIVANOVA USA, INC.
2026-06-26
VNS Therapy™ Programmer, Model 3100 v2.1.0 - Programmer and Software
LIVANOVA USA, INC.
2026-06-24
Perfusion Pack
LIVANOVA USA, INC.
2026-06-08
Perfusion Pack
LIVANOVA USA, INC.
2026-06-08
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-27
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Perfusion Pack
LIVANOVA USA, INC.
2026-05-18
Tubing Organizer - AX-xxxxx
LIVANOVA USA, INC.
2015-09-22
Perfusion Pack
LIVANOVA USA, INC.
2026-05-08
Perfusion Pack
LIVANOVA USA, INC.
2026-05-08
Perfusion Pack
LIVANOVA USA, INC.
2026-05-08

200 records. Showing 1-40. Next