FDA.reportPublic FDA data

Abbott Medical

FDA Registration(s)#

Registration, FEI, Name table
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 key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2049411864801312P970030TORONTO SPV VALVELWR1997-11-04
59311609226794P970013MICRONY PACEMAKERSLWO2000-12-21
3298501609226794P970013MICRONY 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
59311615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
819501615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
3298501615224818P960013TENDRIL 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
59311461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
819501461275087P910023CADENCE(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
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
952821427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
2049411427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
952821072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
2049411072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
2237881072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
952821118222661P230007TriClip G4 SystemNPS2024-04-01
2049411118222661P230007TriClip G4 SystemNPS2024-04-01
952821772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
2237881772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
952821317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
2237881317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
59311957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
819501957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
3298501957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
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
819501326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
952821148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
2162811548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
3099501548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
952821259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
2049411259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
2237881259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
952821128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
3016761128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
952821948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
2049411948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
952821469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
2049411469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
2237881469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
59311599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
819501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
3298501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
59311539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
819501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
3298501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
952821437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
2049411437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
2237881437057228P020024AMPLATZER 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
952821720702331P000039THE 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
2237881720702331P000039THE 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
952821802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
2049411802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
952822051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
2049412051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
952821955780459K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13
2049411955780459K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13
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
952821521462825K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQY2025-12-17
2049411521462825K252417Amplatzer 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
952821514118340K250031Amplatzer GuidewireDQX2025-10-03
2049411514118340K250031Amplatzer GuidewireDQX2025-10-03
952821780190841K243224MitraClip™ 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
3016761780190841K243224MitraClip™ 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
952821430420592K241538TriClip Steerable Guide CatheterDQY2024-08-26
2049411430420592K241538TriClip 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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY622026-06-17
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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PMN#

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