ABBOTT

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1221359	1221359	Abbott Diagnostics Scarborough, Inc.	1	N	2026-01-01	10 Southgate Rd Scarborough ME US 04074
1415939	1415939	ABBOTT LABORATORIES	1	N	2026-01-01	100 ABBOTT PARK RD. Abbott Park IL US 60064
1451914	1451914	ABBOTT LABORATORIES	1	Y	2026-01-01	U.S. 41/MARTIN LUTHER KING DR. North Chicago IL US 60064
1627487	1627487	Abbott Medical	1	N	2026-01-01	6901 Preston Rd PLANO TX US 75024
1628664	1628664	ABBOTT LABORATORIES	1	N	2026-01-01	1921 Hurd Dr IRVING TX US 75038
2017865	2017865	ABBOTT MEDICAL	1	N	2026-01-01	15900 Valley View Court Sylmar CA US 91342
2024168	2024168	ABBOTT VASCULAR	1	Y	2026-01-01	26531 YNEZ RD. Temecula CA US 92591
2135147	3005334138	Abbott Medical	1	N	2026-01-01	5050 NATHAN LANE NORTH Plymouth MN US 55442
2245578	2245578	ABBOTT POINT OF CARE INC.	1	Y	2026-01-01	400 College Road East Princeton NJ US 08540
2630031	2630031	ABBOTT LABORATORIES (PUERTO RICO) INCORPORATED	1	Y	2026-01-01	9615 Ave Los Romeros Ste 700 San Juan PR US 00926
2648612	2648612	Abbott Medical	1	N	2026-01-01	LOT 20 B Street Caguas West Industrial Park Caguas PR US 00725
2919069	2919069	ABBOTT LABORATORIES	1	N	2026-01-01	647 Almanor Ave. Sunnyvale CA US 94085
2939561	3004635528	ABBOTT VASCULAR	1	N	2026-01-01	3200 Lakeside Dr SANTA CLARA CA US 95054
2954323	3002803444	ABBOTT DIABETES CARE INC.	1	Y	2026-01-01	1360 SOUTH LOOP RD. ALAMEDA CA US 94502
3004032053	3004032053	Abbott S.r.l.	1	N	2026-01-01	Viale Thomas Alva Edison, 110 Sesto San Giovanni Milan Lombardy IT 20099
3004936110	3004936110	Abbott Medical	1	N	2026-01-01	387 Nerem St Nw Ste 500 Atlanta GA US 30313
3005070406	3005070406	Abbott Vascular	1	N	2026-01-01	3885 Bohannon Drive Menlo Park CA US 94025
3005128563	3005128563	Abbott Diagnostics (Shanghai) Co., Ltd.	1	N	2026-01-01	151 LIBING ROAD Pilot Free Trade Zone Shanghai CN 201203
3005248192	3005248192	ABBOTT MOLECULAR, INC.	1	Y	2026-01-01	1300 EAST TOUHY AVENUE Des Plaines IL US 60018
3005333358	3005333358	ABBOTT LABORATORIES	1	N	2026-01-01	Conway Park 675 North Field Drive Lake Forest IL US 60045
3005718570	3005718570	ABBOTT VASCULAR	1	N	2026-01-01	CASHEL ROAD CLONMEL Tipperary IE ,
3005737652	3005737652	ABBOTT VASCULAR	1	N	2026-01-01	Building PR-17, Road #2, km 58.0, Cruce Davila Barceloneta PR US 00617
3006412379	3006412379	Abbott Laboratories (Singapore) Private Limited	1	N	2026-01-01	3 Fraser Street #23-28 DUO Tower - Central Singapore SG 189352
3006604866	3006604866	Abbott West Distribution Center	1	Y	2026-01-01	42301 Zevo Drive Temecula CA US 92590
3006705815	3006705815	Abbott Medical	1	Y	2026-01-01	LOT A INTERIOR - No. 2 RD KM 67.5 SANTANA INDUSTRIAL PARK Arecibo PR US 00612

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00810591020017	FIRMap - FIRMap Catheter 50mm, PACKAGED - Abbott (Global)	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020024	FIRMap - FIRMap Catheter 60mm, PACKAGED - Abbott (Global)	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020031	FIRMap - FIRMap Catheter 70mm, PACKAGED - Abbott (Global)	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020062	FIRMap - FIRMap Fan Out Cable - US, Non-Sterile	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020079	FIRMap - FIRMap Extension Cable - Global, Non-Sterile	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020086	FIRMap - FIRMap Mapping Adapter Connector	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020154	RhythmView - USB Memory Stick	+1(650)681-3470	aepcustomerservice@abbott.com
00810591020208	RhythmView - RhythmView Reference Electrode	+1(650)681-3470	aepcustomerservice@abbott.com

abbott.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
2165	1607502001	P980024	PATHVYSION HER-2 DNA PROBE KIT	MVD	1998-12-11
233388	1185492289	P980007	AXSYM FREE PSA	MTG	2004-02-05
204941	1864801312	P970030	TORONTO SPV VALVE	LWR	1997-11-04
2149	1971992102	P970020	MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS	MAF	1997-10-02
2150	1971992102	P970020	MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS	MAF	1997-10-02
2159	1971992102	P970020	MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS	MAF	1997-10-02
5931	1609226794	P970013	MICRONY PACEMAKERS	LWO	2000-12-21
2149	1867642010	P960043	PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM	MGB	1997-04-30
2150	1867642010	P960043	PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM	MGB	1997-04-30
2159	1867642010	P960043	PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM	MGB	1997-04-30
5931	1949371366	P960030	PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS	NVN	1998-01-29
81950	1949371366	P960030	PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS	NVN	1998-01-29
5931	1615224818	P960013	TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS	NVN	1997-06-20
81950	1615224818	P960013	TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS	NVN	1997-06-20
5931	1405123025	P950022	TVL(TM) LEAD SYSTEM	LWS	1996-05-10
81950	1405123025	P950022	TVL(TM) LEAD SYSTEM	LWS	1996-05-10
346967	1497123612	P940035	NMP22 BladderChek Test	NAH	1996-07-02
5931	1461275087	P910023	CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM	LWS	1993-04-30
81950	1461275087	P910023	CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM	LWS	1993-04-30
233388	1256468909	P910007	AXSYM TOTAL PSA & ARCHITECT TOTAL PSA	MTF	1991-09-25
5931	1346726378	P880086	ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS	DXY	1989-08-21
81950	1346726378	P880086	ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS	DXY	1989-08-21
5931	1089540043	P880006	SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM	DXY	1989-02-28
81950	1089540043	P880006	SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM	DXY	1989-02-28
5927	1427691137	P810002	BILEAFLET-CENTER OPENING CARDIAC VALVE	LWQ	1982-12-17
204941	1427691137	P810002	BILEAFLET-CENTER OPENING CARDIAC VALVE	LWQ	1982-12-17
204941	1072781342	P240042	Tendyne Transcatheter Mitral Valve System	NPU	2025-05-23
2149	1961512206	P230036	Esprit™ BTK Everolimus Eluting Resorbable Scaffold System	NXW	2024-04-26
2159	1961512206	P230036	Esprit™ BTK Everolimus Eluting Resorbable Scaffold System	NXW	2024-04-26
123446	1118222661	P230007	TriClip G4 System	NPS	2024-04-01
204941	1118222661	P230007	TriClip G4 System	NPS	2024-04-01
2165	1111492234	P230003	Alinity m HR HPV	MAQ	2023-11-01
2165	1587924514	P210022	Alinity m CMV	PAB	2022-05-05
233388	1513741180	P210003	ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit	LOM	2022-08-10
204941	1772560416	P200049	Amplatzer™ Amulet™ Left Atrial Appendage Occluder	NGV	2021-08-14
2165	1552575489	P200013	Alinity m HBV	MKT	2020-08-29
2165	1805965732	P190025	Alinity m HCV	MZP	2020-03-23
204941	1317995609	P190023	Portico Transcatheter Aortic Valve Implantation System	NPT	2021-09-17
2165	1252645802	P170041	Abbott RealTime IDH1	OWD	2018-07-20
2165	1251071338	P170005	Abbott RealTime IDH2	OWD	2017-08-01
2165	2040089977	P160044	ABBOTT REALTIME CMV	PAB	2017-05-18
2089	1297052832	P160030	Freestyle Libre Flash Glucose Monitoring System	PZE	2017-09-27
2165	1607306097	P150041	VYSIS CLL FISH PROBE KIT	PNK	2016-04-11
5931	1957404550	P150035	Aveir VR Leadless System	PNJ	2022-03-31
81950	1957404550	P150035	Aveir VR Leadless System	PNJ	2022-03-31
2149	1457511207	P150023	ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM	PNY	2016-07-05
2159	1457511207	P150023	ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM	PNY	2016-07-05
2089	1886736038	P150021	FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM	MDS	2016-09-23
5938	1478505081	P150004	Axium Neurostimulator System	PMP	2016-02-11
5931	2051987943	P140033	Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software	LWP	2017-01-31
81950	2051987943	P140033	Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software	LWP	2017-01-31
5938	1326517770	P140009	BRIO NEUROSTIMULATION SYSTEM	MHY	2015-06-12
81950	1326517770	P140009	BRIO NEUROSTIMULATION SYSTEM	MHY	2015-06-12
204941	1148803325	P120021	AMPLATZER PFO OCCLUDER	MLV	2016-10-28
2149	1067542151	P120020	SUPERA PERIPHERAL STENT SYSTEM	NIP	2014-03-28
2159	1067542151	P120020	SUPERA PERIPHERAL STENT SYSTEM	NIP	2014-03-28
2165	1298217069	P120012	ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)	OBF	2013-06-20
233388	1316120706	P120008	ABBOTT ARCHITECT AFP ASSAY	LOK	2012-11-28
2149	1792004051	P110043	OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM	NIO	2012-07-31
2150	1792004051	P110043	OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM	NIO	2012-07-31
2159	1792004051	P110043	OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM	NIO	2012-07-31
233388	1238379979	P110029	ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS	LOM	2012-04-12
2149	1309805090	P110028	ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM	NIO	2012-02-22
2159	1309805090	P110028	ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM	NIO	2012-02-22
2149	1542162583	P110019	Xience Skypoint Everolimus Eluting Coronary Stent System	NIQ	2011-11-01
2150	1542162583	P110019	Xience Skypoint Everolimus Eluting Coronary Stent System	NIQ	2011-11-01
2159	1542162583	P110019	Xience Skypoint Everolimus Eluting Coronary Stent System	NIQ	2011-11-01
82769	1542162583	P110019	Xience Skypoint Everolimus Eluting Coronary Stent System	NIQ	2011-11-01
2165	1913746976	P110012	VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK	OWE	2011-08-26
2149	1469892557	P110001	RX HERCULINK ELITE RENAL STENT SYSTEM	NIN	2011-07-20
2159	1469892557	P110001	RX HERCULINK ELITE RENAL STENT SYSTEM	NIN	2011-07-20
216281	1548003494	P100045	CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM	MOM	2014-05-28
204941	1259362317	P100029	ST JUDE MEDICAL TRIFECTA VALVE	LWR	2011-04-20
2165	1537117142	P100017	ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV	MZP	2011-05-17
2149	1128100614	P100009	MITRACLIP DELIVERY SYSTEM	NKM	2013-10-24
2159	1128100614	P100009	MITRACLIP DELIVERY SYSTEM	NKM	2013-10-24
123446	1128100614	P100009	MITRACLIP DELIVERY SYSTEM	NKM	2013-10-24
204941	1128100614	P100009	MITRACLIP DELIVERY SYSTEM	NKM	2013-10-24
2165	1691443633	P080026	ABBOTT REALTIME HBV ASSAY	MKT	2010-08-13
233388	1571913282	P080023	ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS	SEI	2009-04-10
2149	1727611267	P070015	XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS	NIQ	2008-07-02
2150	1727611267	P070015	XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS	NIQ	2008-07-02
2159	1727611267	P070015	XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS	NIQ	2008-07-02
82769	1727611267	P070015	XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS	NIQ	2008-07-02
233388	1203759096	P060035	ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS	SEI	2007-11-06
233388	1697919650	P050051	ABBOTT ARCHITECT AUSAB	SEI	2006-06-01
233388	1457975421	P050042	ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL	MZO	2006-06-07
2149	1559811470	P050007	STARCLOSE VASCULAR CLOSURE SYSTEM	MGB	2005-12-21
2150	1559811470	P050007	STARCLOSE VASCULAR CLOSURE SYSTEM	MGB	2005-12-21
2159	1559811470	P050007	STARCLOSE VASCULAR CLOSURE SYSTEM	MGB	2005-12-21
204941	1948089994	P040040	AMPLATZER MUSCULAR VSD OCCLUDER	MLV	2007-09-07
2149	1681222287	P040038	XACT CAROTID STENT SYSTEM	NIM	2005-09-06
2159	1681222287	P040038	XACT CAROTID STENT SYSTEM	NIM	2005-09-06
204941	1469465816	P040021	SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE	LWR	2005-08-05
2149	1479612281	P040012	ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM	NIM	2004-08-30
2159	1479612281	P040012	ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM	NIM	2004-08-30
5931	1599943823	P030054	ST JUDE MEDICAL EPIC HF SYSTEM	NIK	2004-06-30
81950	1599943823	P030054	ST JUDE MEDICAL EPIC HF SYSTEM	NIK	2004-06-30
2165	1436424352	P030052	UROVYSION BLADDER CANCER KIT		2005-01-24
5931	1539821199	P030035	ANTHEM AND FRONTIER II CRT-P'S	NKE	2004-05-13
81950	1539821199	P030035	ANTHEM AND FRONTIER II CRT-P'S	NKE	2004-05-13
2149	1963635576	P020047	MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS	MAF	2003-07-16
2150	1963635576	P020047	MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS	MAF	2003-07-16
2159	1963635576	P020047	MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS	MAF	2003-07-16
204941	1437057228	P020024	AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM	MAE	2003-05-14
5931	1213468741	P010032	GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS	LGW	2001-11-21
5938	1213468741	P010032	GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS	LGW	2001-11-21
81950	1213468741	P010032	GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS	LGW	2001-11-21
204941	1720702331	P000039	THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM	MLV	2001-12-05
5938	1772202268	K992946	RENEW RECEIVER	GZB	1999-09-24
2149	1233166198	K992169	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	DQX	1999-10-28
2159	1233166198	K992169	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	DQX	1999-10-28
2087	1470727330	K991605	CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION	GKZ	1999-07-09
2149	1589735738	K991102	COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331	DTL	1999-06-09
2159	1589735738	K991102	COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331	DTL	1999-06-09
233388	1946736143	K991010	ACP	CKB	1999-05-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DQX	112	2025-10-03
DQY	40	2026-07-02
GZB	39	2014-05-02
GKZ	26	2025-02-20
NBW	22	2017-09-27
LOX	18	2022-06-30
LIT	15	2026-02-13
MXC	15	2023-05-17
DRA	14	2022-09-28
NQQ	11	2026-04-24
KRH	9	2009-10-16
JJY	8	2017-03-31
JIT	8	2017-02-15
NIQ	8	2011-11-01
DYB	7	2023-03-01
MAF	7	2003-07-16
GXI	6	2025-05-27
CGA	6	2023-09-11
DHA	6	2023-06-05
QLG	6	2022-05-26
NTE	6	2019-07-25
LDF	6	2016-11-22
JJX	6	2016-10-26
GLQ	6	2011-12-22
FGE	6	2008-08-18
MGB	6	2005-12-21
MMI	5	2025-01-03
CDZ	5	2015-12-17
LFR	5	2015-09-17
JIX	5	2013-01-14
LGW	5	2001-11-21
DLJ	5	2001-08-27
CHL	4	2025-05-02
QAT	4	2024-03-27
JGS	4	2023-10-27
CIG	4	2022-12-29
OCC	4	2017-09-29
NKM	4	2013-10-24
KRD	4	2012-06-12
LOM	4	2012-04-12

PMA#

Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System, Prostar X
2023-01-31
ABBOTT VASCULAR INC.400 Saginaw Driveredwood City, CA 94063 PMA NumberP960043 Supplement NumberS120 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplem...
MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System
2023-01-31
Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS051 Date Received01/03/2023 Decision Date01/31/2023 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
Supera Peripheral Stent System
2023-01-31
ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS030 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIP Advisory Committee Cardiovascular Supplement Type135 Review Track For 3...
XACT Carotid Stent System
2023-01-31
ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040038 Supplement NumberS041 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supple...
StarClose SE Vascular Closure System
2023-01-31
ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS043 Date Received11/21/2022 Decision Date01/31/2023 Product Code MGB Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Sup...
Absolute Pro Vascular Self-Expanding Stent System
2023-01-31
ABBOTT VASCULAR INC.3200 Lakeside Drivesanta Clara, CA 92054 PMA NumberP110028 Supplement NumberS023 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIO Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supple...
RX Acculink Carotid Stent System
2023-01-31
ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040012 Supplement NumberS064 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement ...
ARCHITECT HBsAg Next Qualitative / Next Confirmatory
2023-01-27
Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS005 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process...
Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield™ graft technology (C
2023-01-27
Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP810002 Supplement NumberS116 Date Received12/28/2022 Decision Date01/27/2023 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
ARCHITECT AUSAB / Alinity i Anti-HBs
2023-01-27
ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS049 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement...
ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf
2023-01-27
Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS041 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Pro...
ARCHITECT Free PSA / Alinity i Free PSA
2023-01-27
Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS048 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Cha...
ARCHITECT CORE / Alinity i Anti-HBc
2023-01-27
Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS039 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...
ARCHITECT AFP / Alinity i AFP
2023-01-27
Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS021 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Pr...
ARCHITECT CORE-M / Alinity i Anti-HBc IgM
2023-01-27
Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS037 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process...
ARCHITECT Total PSA / Alinity i Total PSA
2023-01-27
Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS059 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufactur...
FreeStyle Libre 14-day Flash Glucose Monitoring System
2023-01-17
ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS052 Date Received12/19/2022 Decision Date01/17/2023 Product Code PZE Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fe...
Alinity m HBV Assay
2023-01-13
Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS012 Date Received12/20/2022 Decision Date01/13/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/...
RealTime CMV Assay
2023-01-13
ABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS005 Date Received12/20/2022 Decision Date01/13/2023 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...
HeartMate II Left Ventricular Assist System (LVAS)
2023-01-10
Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS089 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Des...
HeartMate 3™ Left Ventricular Assist System (LVAS)
2023-01-10
Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS050 Date Received10/31/2022 Decision Date01/10/2023 Product Code DSQ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Des...
CardioMEMS HF System
2023-01-06
Abbott Medical387 Technology Circle, Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS064 Date Received12/09/2022 Decision Date01/06/2023 Product Code MOM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...
Alinity m HBV
2022-12-22
Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS011 Date Received12/07/2022 Decision Date12/22/2022 Product Code MKT Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason ...
Supera Peripheral Stent System Nylon Pouch
2022-12-20
ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS029 Date Received09/30/2022 Decision Date12/20/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Typereal-time Process Supp...
Prostar™ XL Percutaneous Vascular Surgical System, Perclose ProGlide™ Suture-Mediated Closure System, Perclose™ ProStyle
2022-12-16
ABBOTT VASCULAR INC.400 Saginaw Driveredwood City, CA 94063 PMA NumberP960043 Supplement NumberS119 Date Received11/16/2022 Decision Date12/16/2022 Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...
StarClose SE Vascular Closure System
2022-12-16
ABBOTT VASCULAR DEVICES3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP050007 Supplement NumberS042 Date Received11/16/2022 Decision Date12/16/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System
2022-12-15
Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS050 Date Received11/16/2022 Decision Date12/15/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
Biocor/Epic
2022-12-14
Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP040021 Supplement NumberS051 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
Trifecta
2022-12-14
Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS049 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
Portico™
2022-12-14
Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS011 Date Received11/18/2022 Decision Date12/14/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
ARCHITECT AUSAB/Alinity i Anti-HBs
2022-12-07
ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS048 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement...
ARCHITECT HBsAg Next Qualitative/Next Confirmatory
2022-12-07
Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplem...
ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory
2022-12-07
Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS040 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Sup...
Assurity MRI, Endurity MRI
2022-12-07
Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS076 Date Received09/08/2022 Decision Date12/07/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change ...
IsoFlex
2022-12-07
Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960030 Supplement NumberS077 Date Received09/08/2022 Decision Date12/07/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...
Trifecta™ Valve with Glide Technology™
2022-12-06
Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS048 Date Received10/20/2022 Decision Date12/06/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
2022-12-01
Abbott Molecular, Inc.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Sup...
Trifecta™ Valve with Glide Technology™
2022-11-29
Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS047 Date Received10/20/2022 Decision Date11/29/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...
Alinity m CMV
2022-11-28
Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS002 Date Received11/03/2022 Decision Date11/28/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process ...
Supera Peripheral Stent System
2022-11-22
ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS028 Date Received09/30/2022 Decision Date11/22/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Typereal-time Process Supp...

200 records. Showing 1-40. Next

PMN#

Amplatzer Piccolo? Delivery System (9-PDS-04F-045)
2025-12-17
ABBOTT MEDICAL
EnSite? X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite? X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
2025-09-04
ABBOTT MEDICAL
Alinity m BKV
2025-03-24
Abbott Molecular, Inc.
Alinity m Resp-4-Plex
2025-02-14
Abbott Molecular, Inc.
simpli-COLLECT STI Test
2025-01-30
Abbott Molecular
i-STAT hs-TnI cartridge with the i-STAT 1 System
2025-01-03
Abbott Point of Care, Inc.
MitraClip? G5 Steerable Guide Catheter (SGC0801); TriClip? G5 Steerable Guide Catheter (TSGC0801)
2024-12-31
ABBOTT MEDICAL
Agilis NxT Steerable Introducer Dual-Reach
2024-12-13
ABBOTT MEDICAL
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
2024-12-06
Abbott Molecular
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
2024-11-06
ABBOTT MEDICAL
Alkaline Phosphatase
2024-10-16
Abbott Laboratories Diagnostics Division
Alinity i Toxo IgM
2024-08-30
Abbott Laboratories
TriClip Steerable Guide Catheter
2024-08-26
ABBOTT MEDICAL
EnSite? X EP System
2024-08-09
ABBOTT MEDICAL
Advisor? HD Grid X Mapping Catheter, Sensor Enabled?
2024-07-09
ABBOTT MEDICAL
Agilis? NxT Steerable Introducer Dual-Reach? (I-V2-MED)
2024-06-13
ABBOTT MEDICAL
Libre Rio Continuous Glucose Monitoring System
2024-06-07
Abbott Diabetes Care
Lingo Glucose System
2024-05-29
Abbott
Alinity m HSV 1 & 2 / VZV
2024-05-03
Abbott Molecular, Inc.
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
2024-04-23
Abbott Diabetes Care, Inc.
i-STAT TBI Cartridge with the i-STAT Alinity System
2024-03-27
Abbott Point of Care
CentriMag? Acute Circulatory Support System
2024-01-26
ABBOTT MEDICAL
JETi?Hydrodynamic Thrombectomy System
2023-12-19
ABBOTT MEDICAL
i-STAT CG8+ cartridge with the i-STAT 1 System
2023-10-27
Abbott Point of Care, Inc.
i-STAT CG8+ cartridge with the i-STAT 1 System
2023-10-27
Abbott Point of Care, Inc.
i-STAT CG8+ cartridge with the i-STAT 1 System
2023-10-27
Abbott Point of Care, Inc.
ID NOW Influenza A & B 2
2023-10-10
Abbott Diagnostics Scarborough, Inc.
TBI
2023-09-29
Abbott Laboratories
Amulet? Steerable Delivery Sheath
2023-09-29
ABBOTT MEDICAL
Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer
2023-09-27
Abbott Diagnostics Technologies AS
i-STAT G3+ cartridge with the i-STAT 1 System
2023-09-15
Abbott Point of Care, Inc.
i-STAT G cartridge with the i-STAT 1 System
2023-09-11
Abbott Point of Care, Inc.
ILUMIEN? OPTIS? System, OPTIS? Integrated System, OPTIS? Mobile System, with AptiVue? Imaging Software version E.6
2023-09-08
ABBOTT MEDICAL
HAVAb IgG II
2023-08-10
Abbott Laboratories
ID NOW COVID-19 2.0
2023-08-10
Abbott Diagnostics Scarborough, Inc.
EnSite? X EP System
2023-08-10
ABBOTT MEDICAL
Alinity h-series System
2023-08-04
Abbott Laboratories
i-STAT CG8+ cartridge with the i-STAT 1 System
2023-07-28
Abbott Point of Care, Inc.
Alkaline Phosphatase2
2023-07-21
Abbott Ireland Diagnostics Division
i-STAT PTplus Cartridge with the i-STAT 1 System
2023-07-14
Abbott Laboratories

200 records. Showing 1-40. Next

Applications#

089580
ABBOTT
089579
ABBOTT
089578
ABBOTT
089577
ABBOTT
089576
ABBOTT
089575
ABBOTT
089574
ABBOTT
089573
ABBOTT
089362
ABBOTT
088572
ABBOTT
087980
ABBOTT
087384
ABBOTT
087364
ABBOTT
086333
ABBOTT
085928
ABBOTT
085667
ABBOTT
085518
ABBOTT
085517
ABBOTT
085513
ABBOTT
085447
ABBOTT
084539
ABBOTT
084415
ABBOTT
084414
ABBOTT
084413
ABBOTT
084412
ABBOTT
084411
ABBOTT
084223
ABBOTT
084222
ABBOTT
084166
ABBOTT
084160
ABBOTT
084075
ABBOTT
083159
ABBOTT
083154
ABBOTT
083130
ABBOTT
080389
ABBOTT
080388
ABBOTT
080387
ABBOTT
080386
ABBOTT
080385
ABBOTT
080001
ABBOTT

114 records. Showing 1-40. Next

GUDID#

RhythmView - USB Memory Stick
ABBOTT
2016-09-02
RhythmView - RhythmView Reference Electrode
ABBOTT
2016-09-02
FIRMap - FIRMap Catheter 50mm, PACKAGED - Abbott (Global)
ABBOTT
2016-09-02
FIRMap - FIRMap Catheter 60mm, PACKAGED - Abbott (Global)
ABBOTT
2016-09-02
FIRMap - FIRMap Catheter 70mm, PACKAGED - Abbott (Global)
ABBOTT
2016-09-02
FIRMap - FIRMap Fan Out Cable - US, Non-Sterile
ABBOTT
2016-09-02
FIRMap - FIRMap Extension Cable - Global, Non-Sterile
ABBOTT
2016-09-02
FIRMap - FIRMap Mapping Adapter Connector
ABBOTT
2016-09-02
RhythmView - Assembly, Solid State Drive
ABBOTT
2016-09-02
RhythmView - RhythmView Workstation, US
ABBOTT
2016-09-02
RhythmView - RhythmView Workstation, US, Streaming
ABBOTT
2016-09-02
RhythmView - USB Memory Stick
ABBOTT
2016-09-02
RhythmView - RhythmView Workstation, US, refurbished
ABBOTT
2016-09-02
RhythmView - RhythmView Workstation, US, streaming, refurbished
ABBOTT
2016-09-02
RhythmView - RhythmView Reference Electrode
ABBOTT
2016-09-02
FIRMap - FIRMap Catheter Fan Out Cable (2m) - Abbott (Global), Non-Sterile
ABBOTT
2016-09-02