ABCORP

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

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

• Orilissa

  AbbVie Inc.

  Elagolix

• Orilissa

  AbbVie Inc.

  Elagolix

• Humira

  AbbVie Inc.

  Adalimumab

• Humira

  AbbVie Inc.

  Adalimumab

• Vyalev

  AbbVie Inc.

  foscarbidopa/foslevodopa

• Kaletra

  AbbVie Inc.

  Lopinavir and Ritonavir

• Humira

  AbbVie Inc.

  Adalimumab

• Venclexta

  AbbVie Inc.

  Venetoclax

• Venclexta

  AbbVie Inc.

  Venetoclax

• Venclexta

  AbbVie Inc.

  Venetoclax

• Venclexta

  AbbVie Inc.

  Venetoclax

• Humira

  AbbVie Inc.

  Adalimumab

• Humira

  AbbVie Inc.

  Adalimumab

• Oriahnn

  AbbVie Inc.

  Elagolix and Estradiol and Norethisterone

• Survanta

  AbbVie Inc.

  Beractant

• Rinvoq

  AbbVie Inc.

  Upadacitinib

• 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

• Humira

  AbbVie Inc.

  Adalimumab

• Zemplar

  AbbVie Inc.

  Paricalcitol

• Skyrizi

  AbbVie Inc.

  risankizumab-rzaa

• Lupron Depot-PED

  AbbVie Inc.

  leuprolide acetate

• Lupron Depot-PED

  AbbVie Inc.

  leuprolide acetate

• Rinvoq

  AbbVie Inc.

  Upadacitinib

• Rinvoq

  AbbVie Inc.

  Upadacitinib

• Rinvoq

  AbbVie Inc.

  Upadacitinib

• Norvir

  AbbVie Inc.

  Ritonavir

177 records. Showing 1-40. Next

PMA#

• Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

  2022-05-17

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030035 Supplement NumberS189 Date Received03/07/2022 Decision Date05/17/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• Assurity MRI, Endurity MRI family of Pacemakers

  2022-05-17

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS072 Date Received03/07/2022 Decision Date05/17/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change ...

• Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+

  2022-05-17

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030054 Supplement NumberS398 Date Received03/07/2022 Decision Date05/17/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• Microny family of Pacemakers

  2022-05-17

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP970013 Supplement NumberS090 Date Received03/07/2022 Decision Date05/17/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• Assurity, Assurity+, Endurity, Accent family of Pacemakers

  2022-05-17

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP880086 Supplement NumberS323 Date Received03/07/2022 Decision Date05/17/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• CentriMag™ Circulatory Support System

  2022-05-11

  Abbott6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP170038 Supplement NumberS010 Date Received04/13/2022 Decision Date05/11/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manuf...

• XIENCE Skypoint Everolimus Eluting Coronary Stent System

  2022-05-06

  ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP110019 Supplement NumberS120 Date Received04/06/2022 Decision Date05/06/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Re...

• Alinity m CMV

  2022-05-05

  Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Date Received06/01/2021 Decision Date05/05/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No

• Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M

  2022-05-04

  Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS001 Date Received04/18/2022 Decision Date05/04/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

• FreeStyle Libre 14 day Flash Glucose Monitoring System

  2022-04-28

  ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS051 Date Received04/01/2022 Decision Date04/28/2022 Product Code PZE  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason...

• FreeStyle Libre Pro Flash Glucose Monitoring System

  2022-04-28

  Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS057 Date Received04/01/2022 Decision Date04/28/2022 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Proc...

• Epic Plus Tissue Heart Valves

  2022-04-26

  Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP040021 Supplement NumberS050 Date Received04/06/2022 Decision Date04/26/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Portico™ Transcatheter Aortic Heart Valve

  2022-04-20

  Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS007 Date Received04/18/2022 Decision Date04/20/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Trifecta™ and Trifecta™ Valve with Glide Technology (Trifecta™ GT) valves

  2022-04-14

  Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS046 Date Received03/16/2022 Decision Date04/14/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves

  2022-04-14

  Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP040021 Supplement NumberS049 Date Received03/16/2022 Decision Date04/14/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Impella RP, Impella RP with SmartAssist

  2022-04-12

  Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS038 Date Received03/24/2022 Decision Date04/12/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

• Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist

  2022-04-12

  ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS097 Date Received03/24/2022 Decision Date04/12/2022 Product Code OZD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...

• HeartMate 3™ Left Ventricular Assist System

  2022-04-11

  Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS047 Date Received03/14/2022 Decision Date04/11/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit

  2022-04-11

  Abbott Molecular Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP170005 Supplement NumberS004 Date Received03/10/2022 Decision Date04/11/2022 Product Code OWD  Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Process Ch...

• HeartMate II Left Ventricular Assist System

  2022-04-11

  Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS085 Date Received03/14/2022 Decision Date04/11/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• CentriMag™ Circulatory Support System

  2022-04-01

  Abbott6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP170038 Supplement NumberS009 Date Received03/15/2022 Decision Date04/01/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manuf...

• Aveir VR Leadless System

  2022-03-31

  Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Date Received10/06/2015 Decision Date03/31/2022 Product Code LWO  Advisory Committee Cardiovascular Clinical TrialsNCT01700244 Expedited Review Granted? No

• Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

  2022-03-24

  Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP150004 Supplement NumberS056 Date Received02/22/2022 Decision Date03/24/2022 Product Code PMP  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

• Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

  2022-03-24

  Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS185 Date Received02/22/2022 Decision Date03/24/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

• RX Herculink Elite Renal Stent System

  2022-03-24

  ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP110001 Supplement NumberS018 Date Received02/28/2022 Decision Date03/24/2022 Product Code NIN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

  2022-03-24

  Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS076 Date Received02/22/2022 Decision Date03/24/2022 Product Codes PJS MHY NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - M...

• UroVysion Bladder Cancer Kit

  2022-03-18

  ABBOTT MOLECULAR1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP030052 Supplement NumberS028 Date Received02/18/2022 Decision Date03/18/2022 Product Code NSD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - ...

• PathVysion HER-2 DNA Probe Kit

  2022-03-18

  ABBOTT MOLECULAR, INC.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP980024 Supplement NumberS022 Date Received02/18/2022 Decision Date03/18/2022 Product Code MVD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process C...

• FreeStyle Libre Pro Flash Glucose Monitoring System

  2022-03-16

  Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS056 Date Received02/18/2022 Decision Date03/16/2022 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Proc...

• Impella RP and Impella RP with SmartAssist

  2022-03-16

  Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS036 Date Received12/17/2021 Decision Date03/16/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...

• Freestyle Libre 14-Day Flash Glucose Monitoring System

  2022-03-16

  ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS050 Date Received02/18/2022 Decision Date03/16/2022 Product Code PZE  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason...

• Alinity m HBV

  2022-03-14

  Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS006 Date Received02/17/2022 Decision Date03/14/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...

• Impella RP, Impella RP with SmartAssist

  2022-03-08

  Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS037 Date Received02/09/2022 Decision Date03/08/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...

• Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

  2022-03-08

  ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS095 Date Received02/09/2022 Decision Date03/08/2022 Product Code OZD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...

• Portico Transcatheter Aortic Heart Valve

  2022-03-04

  Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS006 Date Received02/18/2022 Decision Date03/04/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• FreeStyle Libre Pro Flash Glucose Monitoring System

  2022-03-02

  Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS055 Date Received02/01/2022 Decision Date03/02/2022 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Proc...

• Freestyle Libre 14-Day Flash Glucose Monitoring System

  2022-03-02

  ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS049 Date Received02/01/2022 Decision Date03/02/2022 Product Code PZE  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason...

• Spinal Cord Stimulation (SCS) System

  2022-02-17

  Abbott Medical

• Infinity Deep Brain Stimulation (DBS) System

  2022-02-17

  Abbott Medical

• Dorsal Root Ganglion (DRG) System

  2022-02-17

  Abbott Medical

200 records. Showing 121-160. Previous Next

PMN#

• QuadLock? Fixation System

  2026-01-06

  Abanza Tecnomed S.L

• 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.

• WasherCap? Fixation System

  2025-02-25

  Abanza Tecnomed S.L

• Alinity m Resp-4-Plex

  2025-02-14

  Abbott Molecular, Inc.

• WasherCap? Mini Fixation System (Model 45)

  2025-01-30

  Abanza Tecnomed S.L

• 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

• IVD CAPSULE PSP; abioSCOPE

  2024-09-25

  Abionic SA

• 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

• Abiomed 14Fr Low Profile Introducer Kit

  2024-08-06

  Abiomed, Inc.

• 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.

• BiWaze Clear System

  2024-04-08

  Abmrc, LLC

• i-STAT TBI Cartridge with the i-STAT Alinity System

  2024-03-27

  Abbott Point of Care

• Easi-Vue® embolic microspheres System

  2024-02-13

  Abk Biomedical, Inc.

• 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.

• Amulet? Steerable Delivery Sheath

  2023-09-29

  ABBOTT MEDICAL

• TBI

  2023-09-29

  Abbott Laboratories

• 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

200 records. Showing 1-40. Next

Applications#

• 761384

  ABBVIE INC

• 761262

  ABBVIE INC

• 761112

  ABLYNX NV

• 761105

  ABBVIE INC

• 219691

  ABON PHARMS LLC

• 218347

  ABBVIE

• 217906

  ABBVIE

• 217841

  ABON PHARMS LLC

• 217500

  ABSOLUTE AIR, LLC

• 217499

  ABSOLUTE AIR, LLC

• 216962

  ABBVIE

• 216726

  ABON PHARMS LLC

• 215206

  ABBVIE INC

• 215110

  ABBVIE INC

• 214660

  ABBVIE INC

• 214566

  AB PHARMACEUTICALS, LLC

• 214272

  ABON PHARMS LLC

• 214028

  ABBVIE INC

• 213388

  ABBVIE INC

• 212800

  ABHAI INC

• 212453

  ABHAI LLC

• 211675

  ABBVIE INC

• 211499

  ABHAI LLC

• 211106

  ABHAI LLC

• 210707

  ABHAI LLC

• 210644

  ABHAI LLC

• 210510

  ABHAI LLC

• 210450

  ABBVIE INC

• 210371

  ABHAI LLC

• 209512

  ABBVIE INC

• 209394

  ABBVIE INC

• 209335

  ABHAI LLC

• 209037

  ABHAI LLC

• 209036

  ABHAI LLC

• 208624

  ABBVIE INC

• 208593

  ABHAI LLC

• 208573

  ABBVIE INC

• 207931

  ABBVIE INC

• 207488

  ABHAI LLC

• 207487

  ABHAI LLC

200 records. Showing 1-40. Next