Abbott Medical

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• 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...

• 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...

• 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...

• 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...

• 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...

• 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 ...

• 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...

• MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

  2022-11-20

  Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS049 Date Received11/09/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• HeartMate II Left Ventricular Assist System

  2022-11-10

  Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS088 Date Received10/25/2022 Decision Date11/10/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• PorticoTM Transcatheter Aortic Valve Implantation System

  2022-11-09

  Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Des...

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

  2022-10-28

  Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS194 Date Received09/29/2022 Decision Date10/28/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

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

  2022-10-28

  Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS080 Date Received09/29/2022 Decision Date10/28/2022 Product Codes MHY PJS NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - M...

• MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System

  2022-10-17

  Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS048 Date Received10/11/2022 Decision Date10/17/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Deep Brain Stimulation (DBS) System

  2022-10-17

  Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS079 Date Received09/21/2022 Decision Date10/17/2022 Product Code MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufactur...

• HeartMate II™ Left Ventricular Assist System (LVAS)

  2022-10-14

  Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS087 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• HeartMate 3™ Left Ventricular Assist System (LVAS)

  2022-10-14

  Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS049 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Aveir

  2022-10-06

  Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS002 Date Received09/21/2022 Decision Date10/06/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

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

  2022-09-30

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP880086 Supplement NumberS325 Date Received07/27/2022 Decision Date09/30/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• Microny family of Pacemakers

  2022-09-30

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP970013 Supplement NumberS091 Date Received07/27/2022 Decision Date09/30/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• Assurity MRI, Endurity MRI family of Pacemakers

  2022-09-30

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS075 Date Received07/27/2022 Decision Date09/30/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change ...

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

  2022-09-30

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030035 Supplement NumberS191 Date Received07/27/2022 Decision Date09/30/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Desig...

• CardioMEMS™ HF System

  2022-09-15

  Abbott Medical387 Technology Circle, Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS063 Date Received08/18/2022 Decision Date09/15/2022 Product Code MOM  Advisory Committee Cardiovascular Clinical TrialsNCT02279888 Supplement Typenormal 18...

• Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR

  2022-09-09

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP910023 Supplement NumberS448 Date Received08/24/2022 Decision Date09/09/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

• Spinal Cord Stimulation (SCS)

  2022-09-09

  Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS190 Date Received08/11/2022 Decision Date09/09/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

• MitraClip™ Clip Delivery System

  2022-09-09

  Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS047 Date Received08/25/2022 Decision Date09/09/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF

  2022-09-09

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030054 Supplement NumberS402 Date Received08/24/2022 Decision Date09/09/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

• Proclaim DRG Systems

  2022-08-19

  Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP150004 Supplement NumberS057 Date Received05/23/2022 Decision Date08/19/2022 Product Code PMP  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components...

• MitraClip G4 Clip Delivery System

  2022-08-16

  Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS046 Date Received07/22/2022 Decision Date08/16/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

• MitraClip™ G4 Clip Delivery System

  2022-08-08

  Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS045 Date Received01/31/2022 Decision Date08/08/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Re...

• Quickflex µ, Quartet

  2022-08-01

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030054 Supplement NumberS400 Date Received07/14/2022 Decision Date08/01/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

• Tendril MRI

  2022-08-01

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS074 Date Received07/14/2022 Decision Date08/01/2022 Product Codes NVN LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

• OptiSense, Tendril STS, Tendril SDX, Tendril ST

  2022-08-01

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960013 Supplement NumberS121 Date Received07/14/2022 Decision Date08/01/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

• Durata, Optisure

  2022-08-01

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP950022 Supplement NumberS143 Date Received07/14/2022 Decision Date08/01/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

• IsoFlex

  2022-08-01

  Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960030 Supplement NumberS076 Date Received07/14/2022 Decision Date08/01/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change -...

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

• 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

• Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

  2024-11-06

  ABBOTT MEDICAL

• 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

• CentriMag? Acute Circulatory Support System

  2024-01-26

  ABBOTT MEDICAL

• JETi?Hydrodynamic Thrombectomy System

  2023-12-19

  ABBOTT MEDICAL

• Amulet? Steerable Delivery Sheath

  2023-09-29

  ABBOTT MEDICAL

• ILUMIEN? OPTIS? System, OPTIS? Integrated System, OPTIS? Mobile System, with AptiVue? Imaging Software version E.6

  2023-09-08

  ABBOTT MEDICAL

• EnSite? X EP System

  2023-08-10

  ABBOTT MEDICAL

• ViewFlex? Eco Reprocessed ICE Catheter

  2023-06-30

  ABBOTT MEDICAL

• CPS Direct? Universal slittable outer guide catheter (DS2C029)

  2023-06-02

  ABBOTT MEDICAL

• Assert-IQ? Insertable Cardiac Monitor

  2023-05-17

  ABBOTT MEDICAL

• ViewFlex? Eco Reprocessed ICE Catheter

  2023-05-03

  ABBOTT MEDICAL

• Dragonfly OpStar? Imaging Catheter

  2023-04-14

  ABBOTT MEDICAL

• Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 4054

  2023-03-01

  ABBOTT MEDICAL

• EnSite? X EP System TactiFlex? Ablation Catheter, Sensor Enabled?, Software Upgrade; EnSite? X EP System TactiFlex? Ablation Catheter, Sensor Enabled?, Software License

  2022-12-27

  ABBOTT MEDICAL

• ViewFlex Xtra Reprocessed ICE Catheter

  2022-12-19

  ABBOTT MEDICAL

• MitraClip G4 Steerable Guide Catheter

  2022-09-28

  Abbott Medical

• CPS AIM Universal II Slittable Inner Catheter

  2022-06-30

  Abbott Medical

• Ultiri Measurement System

  2022-04-30

  ABBOTT MEDICAL

• Aveir Retrieval Catheter

  2022-04-01

  Abbott Medical

• Amplatzer Steerable Delivery Sheath

  2022-03-09

  Abbott Medical

• Abbott Medical Grounding Pad, Model RF-DGP-IS

  2022-01-21

  Abbott Medical

• EnSite X EP System

  2021-11-11

  Abbott Medical

• Amplatzer Talisman Delivery Sheath

  2021-09-27

  ABBOTT MEDICAL

• Amplatzer Steerable Delivery Sheath

  2021-09-27

  ABBOTT MEDICAL

• Aveir Introducer

  2021-07-27

  Abbott Medical

• OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

  2021-06-08

  Abbott Medical

• EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled

  2020-11-25

  Abbott Medical

• IonicRF Generator

  2020-10-21

  Abbott Medical

• EnSite Precision Cardiac Mapping System V2.6, EnSite Precision Software Installation V2.6, EnSite LiveView Dynamic Display Software License

  2020-06-26

  Abbott Medical

• EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

  2020-06-26

  Abbott Medical

• ILUMIEN System With AptiVue Software Version D.3

  2019-12-17

  Abbott Medical

• Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.1

  2019-11-08

  Abbott Medical

• Advisor VL Circular Mapping Catheter, Sensor Enabled

  2019-09-17

  Abbott Medical

56 records. Showing 1-40. Next