FDA.reportPublic FDA data

ABBOTT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12213591221359Abbott Diagnostics Scarborough, Inc.1N2026-01-0110 Southgate Rd Scarborough ME US 04074
14159391415939ABBOTT LABORATORIES1N2026-01-01100 ABBOTT PARK RD. Abbott Park IL US 60064
14519141451914ABBOTT LABORATORIES1Y2026-01-01U.S. 41/MARTIN LUTHER KING DR. North Chicago IL US 60064
16274871627487Abbott Medical1N2026-01-016901 Preston Rd PLANO TX US 75024
16286641628664ABBOTT LABORATORIES1N2026-01-011921 Hurd Dr IRVING TX US 75038
20178652017865ABBOTT MEDICAL1N2026-01-0115900 Valley View Court Sylmar CA US 91342
20241682024168ABBOTT VASCULAR1Y2026-01-0126531 YNEZ RD. Temecula CA US 92591
21351473005334138Abbott Medical1N2026-01-015050 NATHAN LANE NORTH Plymouth MN US 55442
22455782245578ABBOTT POINT OF CARE INC.1Y2026-01-01400 College Road East Princeton NJ US 08540
26300312630031ABBOTT LABORATORIES (PUERTO RICO) INCORPORATED1Y2026-01-019615 Ave Los Romeros Ste 700 San Juan PR US 00926
26486122648612Abbott Medical1N2026-01-01LOT 20 B Street Caguas West Industrial Park Caguas PR US 00725
29190692919069ABBOTT LABORATORIES1N2026-01-01647 Almanor Ave. Sunnyvale CA US 94085
29395613004635528ABBOTT VASCULAR1N2026-01-013200 Lakeside Dr SANTA CLARA CA US 95054
29543233002803444ABBOTT DIABETES CARE INC.1Y2026-01-011360 SOUTH LOOP RD. ALAMEDA CA US 94502
30040320533004032053Abbott S.r.l.1N2026-01-01Viale Thomas Alva Edison, 110 Sesto San Giovanni Milan Lombardy IT 20099
30049361103004936110Abbott Medical1N2026-01-01387 Nerem St Nw Ste 500 Atlanta GA US 30313
30050704063005070406Abbott Vascular1N2026-01-013885 Bohannon Drive Menlo Park CA US 94025
30051285633005128563Abbott Diagnostics (Shanghai) Co., Ltd.1N2026-01-01151 LIBING ROAD Pilot Free Trade Zone Shanghai CN 201203
30052481923005248192ABBOTT MOLECULAR, INC.1Y2026-01-011300 EAST TOUHY AVENUE Des Plaines IL US 60018
30053333583005333358ABBOTT LABORATORIES1N2026-01-01Conway Park 675 North Field Drive Lake Forest IL US 60045
30057185703005718570ABBOTT VASCULAR1N2026-01-01CASHEL ROAD CLONMEL Tipperary IE ,
30057376523005737652ABBOTT VASCULAR1N2026-01-01Building PR-17, Road #2, km 58.0, Cruce Davila Barceloneta PR US 00617
30064123793006412379Abbott Laboratories (Singapore) Private Limited1N2026-01-013 Fraser Street #23-28 DUO Tower - Central Singapore SG 189352
30066048663006604866Abbott West Distribution Center1Y2026-01-0142301 Zevo Drive Temecula CA US 92590
30067058153006705815Abbott Medical1Y2026-01-01LOT 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 GUDIDProductPhoneEmail
00810591020017FIRMap - FIRMap Catheter 50mm, PACKAGED - Abbott (Global)+1(650)681-3470aepcustomerservice@abbott.com
00810591020024FIRMap - FIRMap Catheter 60mm, PACKAGED - Abbott (Global)+1(650)681-3470aepcustomerservice@abbott.com
00810591020031FIRMap - FIRMap Catheter 70mm, PACKAGED - Abbott (Global)+1(650)681-3470aepcustomerservice@abbott.com
00810591020062FIRMap - FIRMap Fan Out Cable - US, Non-Sterile+1(650)681-3470aepcustomerservice@abbott.com
00810591020079FIRMap - FIRMap Extension Cable - Global, Non-Sterile+1(650)681-3470aepcustomerservice@abbott.com
00810591020086FIRMap - FIRMap Mapping Adapter Connector+1(650)681-3470aepcustomerservice@abbott.com
00810591020154RhythmView - USB Memory Stick+1(650)681-3470aepcustomerservice@abbott.com
00810591020208RhythmView - RhythmView Reference Electrode+1(650)681-3470aepcustomerservice@abbott.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
21651607502001P980024PATHVYSION HER-2 DNA PROBE KITMVD1998-12-11
2333881185492289P980007AXSYM FREE PSAMTG2004-02-05
2049411864801312P970030TORONTO SPV VALVELWR1997-11-04
21491971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
21501971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
21591971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
59311609226794P970013MICRONY PACEMAKERSLWO2000-12-21
21491867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
21501867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
21591867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
59311949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
819501949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59311615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
819501615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
59311405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
819501405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
3469671497123612P940035NMP22 BladderChek TestNAH1996-07-02
59311461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
819501461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
2333881256468909P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF1991-09-25
59311346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
819501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
59311089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
819501089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
59271427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
2049411427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
2049411072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
21491961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
21591961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
1234461118222661P230007TriClip G4 SystemNPS2024-04-01
2049411118222661P230007TriClip G4 SystemNPS2024-04-01
21651111492234P230003Alinity m HR HPVMAQ2023-11-01
21651587924514P210022Alinity m CMVPAB2022-05-05
2333881513741180P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitLOM2022-08-10
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
21651552575489P200013Alinity m HBVMKT2020-08-29
21651805965732P190025Alinity m HCVMZP2020-03-23
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
21651252645802P170041Abbott RealTime IDH1OWD2018-07-20
21651251071338P170005Abbott RealTime IDH2OWD2017-08-01
21652040089977P160044ABBOTT REALTIME CMVPAB2017-05-18
20891297052832P160030Freestyle Libre Flash Glucose Monitoring SystemPZE2017-09-27
21651607306097P150041VYSIS CLL FISH PROBE KITPNK2016-04-11
59311957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
819501957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
21491457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
21591457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
20891886736038P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEMMDS2016-09-23
59381478505081P150004Axium Neurostimulator SystemPMP2016-02-11
59312051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
819502051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
59381326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
819501326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
21491067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21591067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21651298217069P120012ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)OBF2013-06-20
2333881316120706P120008ABBOTT ARCHITECT AFP ASSAYLOK2012-11-28
21491792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21501792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21591792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
2333881238379979P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLSLOM2012-04-12
21491309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
21591309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
21491542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21501542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21591542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
827691542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21651913746976P110012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKOWE2011-08-26
21491469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
21591469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
2162811548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
2049411259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
21651537117142P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCVMZP2011-05-17
21491128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21591128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
1234461128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21651691443633P080026ABBOTT REALTIME HBV ASSAYMKT2010-08-13
2333881571913282P080023ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLSSEI2009-04-10
21491727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21501727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21591727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
827691727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
2333881203759096P060035ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSSEI2007-11-06
2333881697919650P050051ABBOTT ARCHITECT AUSABSEI2006-06-01
2333881457975421P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLMZO2006-06-07
21491559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
21501559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
21591559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
2049411948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
21491681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
21591681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
2049411469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
21491479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
21591479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
59311599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
819501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
21651436424352P030052UROVYSION BLADDER CANCER KIT2005-01-24
59311539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
819501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
21491963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
21501963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
21591963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
2049411437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
59311213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
59381213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
819501213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
2049411720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
59381772202268K992946RENEW RECEIVERGZB1999-09-24
21491233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
21591233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
20871470727330K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTIONGKZ1999-07-09
21491589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
21591589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
2333881946736143K991010ACPCKB1999-05-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX1112025-10-03
GZB392014-05-02
DQY362025-12-17
GKZ262025-02-20
NBW222017-09-27
LOX182022-06-30
LIT152026-02-13
MXC152023-05-17
DRA142022-09-28
NQQ112026-04-24
KRH92009-10-16
JJY82017-03-31
JIT82017-02-15
NIQ82011-11-01
DYB72023-03-01
MAF72003-07-16
GXI62025-05-27
CGA62023-09-11
DHA62023-06-05
QLG62022-05-26
NTE62019-07-25
LDF62016-11-22
JJX62016-10-26
GLQ62011-12-22
FGE62008-08-18
MGB62005-12-21
MMI52025-01-03
CDZ52015-12-17
LFR52015-09-17
JIX52013-01-14
LGW52001-11-21
DLJ52001-08-27
CHL42025-05-02
QAT42024-03-27
JGS42023-10-27
CIG42022-12-29
OCC42017-09-29
NKM42013-10-24
KRD42012-06-12
LOM42012-04-12

PMA#

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...

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 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...

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...

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...

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...

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...

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TBI

2023-09-29

Abbott Laboratories

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