FDA.reportPublic FDA data

ABCORP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10648513000135139ABATEMENT TECHNOLOGIES, INC.1Y2026-01-01605 Satellite Blvd NW Ste 300 SUWANEE GA US 30024
12157091215709ABCORP1N2026-01-01225 Rivermoor St Boston MA US 02132
12206481220648ABIOMED, INC.1N2026-01-0122 Cherry Hill Dr DANVERS MA US 01923
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
15258381525838ABRASIVE TECHNOLOGY, LLC1Y2026-01-018400 Green Meadows Drive N. LEWIS CENTER OH US 43035
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
20857213000219565ABBA OPTICAL1Y2026-01-016396 Roland St Buena Park CA US 90621
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
29165472916547ABB Optical Group LLC.1N2026-01-013901 Ne 33rd Ter Ste E Kansas City MO US 64117
29190692919069ABBOTT LABORATORIES1N2026-01-01647 Almanor Ave. Sunnyvale CA US 94085
29395613004635528ABBOTT VASCULAR1N2026-01-013200 Lakeside Dr SANTA CLARA CA US 95054
29396932939693ABAXIS, INC.1N2026-01-013240 WHIPPLE RD. UNION CITY CA US 94587
29543233002803444ABBOTT DIABETES CARE INC.1Y2026-01-011360 SOUTH LOOP RD. ALAMEDA CA US 94502
80439913004017406ABIGO MEDICAL AB1N2026-01-01MOLNDALS BRO 2 MOLNDAL Vastra Gotaland SE 431 31
96803043002807657Abrar Solatch1N2026-01-01503 W Pleasant Grove Road Westchester PA US 19382
10002024621000202462AB MEDICA GROUP S. A.1N2026-01-01Calle Jerico 10 Bis Interior Barcelona ES 08035
30001351383000135138ABATEMENT TECHNOLOGIES LIMITED1N2026-01-011481 Harber Court FORT ERIE Ontario CA L2A 0G3

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2049411864801312P970030TORONTO SPV VALVELWR1997-11-04
21491971992102P970020MULTI-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
21591867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
59311949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59311615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
59311405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
3469671497123612P940035NMP22 BladderChek TestNAH1996-07-02
59311461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
15141655575937P900023ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEMDSQ1992-11-20
59311346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
59311089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
1281901240131723P820051
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
2049411118222661P230007TriClip G4 SystemNPS2024-04-01
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
15141597260964P170011Impella RP SystemPYX2017-09-20
20891297052832P160030Freestyle Libre Flash Glucose Monitoring SystemPZE2017-09-27
59311957404550P150035Aveir 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
59381326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
15141655437629P140003IMPELLA 2.5 SystemOZD2015-03-23
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
21491067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21591067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21491792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21591792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
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
21591542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21491469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
21591469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
2049411259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
21491128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21591128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21491727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21591727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21491559811470P050007STARCLOSE 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
59311539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
21491963635576P020047MULTI-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
2049411720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
423421273158649K993211PICCOLO SODIUM TEST SYSTEMJGS1999-10-25
59381772202268K992946RENEW RECEIVERGZB1999-09-24
1281901404294023K992466OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEARLPL1999-10-04
21491233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
21591233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
423421030602779K992140PICCOLO METLYTE 7 REAGENT DISCJLB1999-08-26
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
21491208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
21591208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
59381135856364K990469LAMITRODE LEADSGZB1999-06-03
21491267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
21591267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
179331488390354K984116HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400CFRF1999-06-24
179341488390354K984116HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400CFRF1999-06-24
21491757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
21591757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
21491210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
21591210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
20871331970531K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
21491576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
21591576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
21491412691795K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQX1998-03-13
21591412691795K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQX1998-03-13
20921950296043K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
21491887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
21591887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
21492053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21592053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21491439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
21591439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
21491725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
21591725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
21491879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
21591879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
59382023801547K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)GZB1996-05-22
3469671137616619K960712BINAX STREP A TESTGTZ1996-03-22
1281901176353202K960291TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENSLPL1996-03-25
21491748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
21591748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
423421389889655K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORCHH1995-04-13
21491469853050K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQX1995-04-05
21591469853050K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQX1995-04-05
59311921274733K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069DTD1995-04-06
423421337321834K942782PICCOLO(TM)JJG1995-03-13
21491449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
21591449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
1281901082363589K941998OCU-FLEX-38 (POLYMACON)LPL1994-10-13
59381780816653K941342PAIN DOCGZB1995-10-13
423421539111664K935181ASPARTATE AMINOTRANSFERASE (AST) TESTCIT1994-01-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX972025-10-03
GZB382014-05-02
DQY362026-04-24
NBW222017-09-27
LOX182022-06-30
MXC152023-05-17
GKZ132025-02-20
LIT122026-02-13
NQQ112026-04-24
DYB112023-03-01
DRA92019-05-29
KRH92009-10-16
LPL92002-12-10
GXI62025-05-27
CGA62023-09-11
QLG62022-05-26
NTE62019-07-25
LDF62016-11-22
FGE62008-08-18
FRO52017-08-21
LFR52015-09-17
MAF52003-07-16
CHL42025-05-02
JGS42023-10-27
KRD42012-06-12
NIQ42011-11-01
MGB42005-12-21
DTL41999-06-09
MAV41996-09-12
QBJ32024-04-23
DQO32023-04-14
GXD32020-10-21
OCC32017-09-29
MLV32016-10-28
NKM32013-10-24
GLQ32011-12-22
DSA32010-04-02
DRB32009-04-01
LGW32001-11-21
MXD22025-12-18

NDC#

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Creon

AbbVie Inc.

Pancrelipase

Vyalev

AbbVie Inc.

foscarbidopa/foslevodopa

Kaletra

AbbVie Inc.

Lopinavir and Ritonavir

Oriahnn

AbbVie Inc.

Elagolix and Estradiol and Norethisterone

EMRELIS

AbbVie Inc.

Telisotuzumab Vedotin

Skyrizi

AbbVie Inc.

risankizumab-rzaa

EMRELIS

AbbVie Inc.

Telisotuzumab Vedotin

Skyrizi

AbbVie Inc.

Risankizumab-rzaa

Skyrizi

AbbVie Inc.

Risankizumab-rzaa

Skyrizi

AbbVie Inc.

risankizumab-rzaa

177 records. Showing 1-40. Next

PMA#

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 ...

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...

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...

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...

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...

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 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 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 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...

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...

Impella2.5, ImpellaCP, Impella CP with SmartAssist

2023-01-06

ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change -...

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...

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...

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...

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...

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...

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 ...

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...

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...

Impella RP, Impella RP with SmartAssist

2022-12-05

Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...

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...

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TBI

2023-09-29

Abbott Laboratories

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