FDA.report

Abbott Medical

Matched from indexed company URL: ABBOTT MEDICAL

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16274871627487Abbott Medical1N2026-01-016901 Preston Rd PLANO TX US 75024
20178652017865ABBOTT MEDICAL1N2026-01-0115900 Valley View Court Sylmar CA US 91342
21351473005334138Abbott Medical1N2026-01-015050 NATHAN LANE NORTH Plymouth MN US 55442
26486122648612Abbott Medical1N2026-01-01LOT 20 B Street Caguas West Industrial Park Caguas PR US 00725
30049361103004936110Abbott Medical1N2026-01-01387 Nerem St Nw Ste 500 Atlanta GA US 30313
30067058153006705815Abbott Medical1Y2026-01-01LOT A INTERIOR - No. 2 RD KM 67.5 SANTANA INDUSTRIAL PARK Arecibo PR US 00612
30071134873007113487Abbott Medical1N2026-01-01177 County Road B East Saint Paul MN US 55117
30096000983009600098Abbott Medical1N2026-01-014 Robbins Rd Westford MA US 01886
30117067993011706799Abbott Medical1N2026-01-011850 MacArthur Blvd NW Suite B Atlanta GA US 30318
30132882013013288201ABBOTT MEDICAL1N2026-01-0114901 Deveau Pl. Building 2 Minnetonka MN US 55345
30149189773014918977Abbott Medical Costa Rica Limitada (Structural Heart)1N2026-01-01Edificio #44 Calle 0, Ave. 2 Zona Franca Coyol El Coyol Alajuela CR 20113
30209508183020950818Abbott Medical1N2026-01-011820 Bastian Court Westfield IN US 46074
30389666333038966633Abbott Medical Mexico, S. de R.L. de C.V.1N2026-01-01Avenida FINSA 156, Lote 12 Parque Industrial FINSA III Santa Rosa Jauregui Queretaro MX C.P. 76223
30100686583010068658Abbott Medical1N2020-04-25177 County Road B East Saint Paul MN US 55117

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2049411864801312P970030Toronto Spv Valve1997-11-04
3298501609226794P970013MICRONY PACEMAKERSLWO2000-12-21
59311609226794P970013MICRONY PACEMAKERSLWO2000-12-21
59311949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
819501949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
3298501949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
3298501615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
819501615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
59311615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
59311405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
819501405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
3298501405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
819501461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
59311461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
59311346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
819501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
3298501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
819501089540043P880006Sensolog Model 703 Pulse Generator & P700 Programm1989-02-28
59311089540043P880006Sensolog Model 703 Pulse Generator & P700 Programm1989-02-28
2049411427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
952821427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
59271427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
952821072781342P2400421969-12-31
2049411072781342P2400421969-12-31
2237881072781342P2400421969-12-31
952821118222661P2300071969-12-31
2049411118222661P2300071969-12-31
952821772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV 2021-08-14
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV 2021-08-14
2237881772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV 2021-08-14
952821317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT 2021-09-17
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT 2021-09-17
2237881317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT 2021-09-17
59311957404550P150035Aveir VR Leadless SystemLWO 2022-03-31
819501957404550P150035Aveir VR Leadless SystemLWO 2022-03-31
3298501957404550P150035Aveir VR Leadless SystemLWO 2022-03-31
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
3298502051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
59381326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
59381326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
819501326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
952821148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
2162811548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
3099501548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
2237881259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
2049411259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
952821259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
952821128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
3016761128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
952821948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
2049411469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
2237881469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
952821469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
59311599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
3298501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
819501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
59311539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
3298501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
819501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
2237881437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
2049411437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
952821437057228P020024AMPLATZER 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
59381213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
819501213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
819501213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
952821720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
2237881720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
2049411720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
59381772202268K992946RENEW RECEIVERGZB1999-09-24
59381135856364K990469LAMITRODE LEADSGZB1999-06-03
59382023801547K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)GZB1996-05-22
819502023801547K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)GZB1996-05-22
59311921274733K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069DTD1995-04-06
59381780816653K941342PAIN DOCGZB1995-10-13
952821426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
2049411426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
59381971527699K930536NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM RECGZB1994-12-15
59381551150553K930498NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRANGZB1994-12-12
59381821119545K930242INTRODE INT-8GZB1994-02-02
59311583375331K921318ADAPTING SLEEVE KIT MODEL 4023DTD1992-08-03
3298501071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
3298501900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
59381427850039K903814NEUROMED TS8 TEST STIMULATORGZB1991-01-16
3298501708793242K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDF1988-02-12
59311400711123K253516Assert-IQ (DM5100)MXD2025-12-18
2079951263121909K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)NQQ2026-04-24
2049411521462825K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQY2025-12-17
952821521462825K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQY2025-12-17
3451821826487014K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJ2025-05-20
59311925374185K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD2025-09-17
3451821219462594K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJ2025-05-23
952821557844089K250426Amulet™ Steerable Delivery SheathDQY2025-04-25
2049411557844089K250426Amulet™ Steerable Delivery SheathDQY2025-04-25
2049411514118340K250031Amplatzer GuidewireDQX2025-10-03
952821514118340K250031Amplatzer GuidewireDQX2025-10-03
3016761780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
2049411780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
952821780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
59381892153185K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI2025-05-27
2049411430420592K241538TriClip Steerable Guide CatheterDQY2024-08-26
952821430420592K241538TriClip Steerable Guide CatheterDQY2024-08-26
952821165671949K232690Amulet™ Steerable Delivery SheathDQY2023-09-29
2049411165671949K232690Amulet™ Steerable Delivery SheathDQY2023-09-29
2079951362972053K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6NQQ2023-09-08
59311947944437K231311CPS Direct™ Universal slittable outer guide catheter (DS2C029)DQY2023-06-02
2079951902982090K230411Dragonfly OpStar™ Imaging CatheterDQO2023-04-14
59311284508201K230286Assert-IQ™ Insertable Cardiac MonitorMXC2023-05-17
59311417024881K230283Peel-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, 405422, 405424, 405428)DYB2023-03-01
59312038621226K221750CPS AIM Universal II Slittable Inner CatheterDQY2022-06-30
3298502038621226K221750CPS AIM Universal II Slittable Inner CatheterDQY2022-06-30
952821033547631K221397MitraClip G4 Steerable Guide CatheterDRA2022-09-28
2079951102114316K220243Ultiri Measurement SystemDQK2022-04-30
59311142530934K213494Aveir Retrieval CatheterMMX2022-04-01

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQY562025-12-17
GZB392014-05-02
MXC152023-05-17
KRH142009-10-16
NQQ122026-04-24
DQX112025-10-03
KRD82012-06-12
MLV72016-10-28
GXI62025-05-27
DYB62023-03-01
DRA62022-09-28
LWR62011-04-20
NVN61998-01-29
LGW52001-11-21
LWS51996-05-10
DQO42023-04-14
LDF42016-11-22
DQK32022-04-30
LWO 32022-03-31
NPT 32021-09-17
NGV 32021-08-14
GXD32020-10-21
LWP32017-01-31
MHY32015-06-12
NKM32013-10-24
DRB32009-04-01
NIK32004-06-30
NKE32004-05-13
MAE32003-05-14
DXY31989-08-21
LWQ31982-12-17
MXD22025-12-18
OBJ22025-05-23
MMX22022-04-01
GXR22018-07-20
MOM22014-05-28
DXC22011-02-24
DSA22010-04-02
MJN22005-12-30
LWO22000-12-21

PMA

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...

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...

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...

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...

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 -...

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