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
30209508183020950818Abbott Medical1N2026-01-011820 Bastian Court Westfield IN US 46074
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
819501949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59311949371366P960030PASSIVE 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
819501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
59311346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
3298501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
819501089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
59311089540043P880006SENSOLOG 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
2049411118222661P230007TriClip G4 SystemNPS2024-04-01
952821118222661P230007TriClip G4 SystemNPS2024-04-01
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
952821772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
952821317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
59311957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
3298501957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
819501957404550P150035Aveir 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
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
952821148803325P120021AMPLATZER 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
3016761128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
952821128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
952821948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
952821469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
2049411469465816P040021SJM 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
2049411437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
952821437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
59381213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
819501213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
59311213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
2049411720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
952821720702331P000039THE 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
2049411426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
952821426393649K935170CARDIOVASCULAR 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
2049411961154169K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY2026-07-02
952821961154169K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY2026-07-02
2049411802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
952821802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
2049412051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
952822051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
2049411955780459K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13
952821955780459K260499Amplatzer™ 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
59311925374185K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD2025-09-17
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
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
3298501142530934K213494Aveir Retrieval CatheterMMX2022-04-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY642026-07-02
GZB392014-05-02
MXC152023-05-17
KRH142009-10-16
NQQ122026-04-24
DQX112025-10-03
KRD82012-06-12
DYB72023-03-01
GXI62025-05-27
DRA62022-09-28
MLV62016-10-28
NVN61998-01-29
LGW52001-11-21
LWS51996-05-10
DQO42023-04-14
GXD42022-01-21
LDF42016-11-22
LWR42011-04-20
DQK32022-04-30
LWO 32022-03-31
LWP32017-01-31
MHY32015-06-12
NKM32013-10-24
DRB32009-04-01
NIK32004-06-30
NKE32004-05-13
DXY31989-08-21
LWQ31982-12-17
MXD22025-12-18
MMX22022-04-01
NPT 22021-09-17
NGV 22021-08-14
GXR22018-07-20
MOM22014-05-28
DXC22011-02-24
DSA22010-04-02
MJN22005-12-30
MAE22003-05-14
LWO22000-12-21
DTD21995-04-06

PMA#

200 records. Showing 1-40. Next

PMN#

41 records. Showing 1-40. Next