FDA.reportPublic FDA data

MEDTRONIC, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21822082182208MEDTRONIC, INC.1N2026-01-018200 Coral Sea Street NE Mounds View MN US 55112
30015049943001504994Medtronic, Inc.1Y2026-01-01710 Medtronic Parkway Minneapolis MN US 55432
30041857813004185781Medtronic, Inc.1N2026-01-012343 W. Medtronic Way Tempe AZ US 85281
30125206543012520654MEDTRONIC, INC.1N2026-01-01880 Technology Park Drive Billerica MA US 01821
30155447463015544746Medtronic, Inc.1N2026-01-017000 Central Ave., N.E. Minneapolis MN US 55432
30075662373007566237Medtronic, Inc.1N2020-04-25800 53RD AVE., N.E. Minneapolis MN US 55421

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00763000001513Primo MRI™ DR SureScan™ - ICD-DR DDMD3D4 PRIMO MRI US+1(800)633-8766Corporate.UDI@medtronic.com
00763000001551Primo MRI™ VR SureScan™ - ICD-VR DVMD3D4 PRIMO MRI US+1(800)633-8766Corporate.UDI@medtronic.com
00763000059491Evera MRI™ XT DR SureScan® - ICD-DR DDMB1D4 EVERA MRI XT US IS1/DF4+1(800)633-8766Corporate.UDI@medtronic.com
00763000368470Aurora EV-ICD™ MRI SureScan™ - ICD-VR DVEA3E4 EV-ICD EV4 US RW UPDATE+1(800)633-8766Corporate.UDI@medtronic.com
00763000443214NA - ABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR+1(800)633-8766Corporate.UDI@medtronic.com
00763000923594HeartWare™ Monitor - MONITOR 1521MCS KIT+1(800)633-8766Corporate.UDI@medtronic.com
00763000923709Power Cord - CORD MCS1621PC - POWER US CA TW+1(800)633-8766Corporate.UDI@medtronic.com
00763000923792Monitor Power Cord - CORD MCS1622PC - MON POWER US CA TW+1(800)633-8766Corporate.UDI@medtronic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58011309515697P990001DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2NVZ1999-09-27
58011877254910P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS2000-06-14
58011232151429P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
58011178418077P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS1998-10-09
58011925563044P970012MEDTRONIC.KAPPA 400 SERIES PACEMAKERSNVZ1998-01-30
58011620496774P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568NVN1996-03-29
58011317666566P930029ATAKR(TM) RFCA SYSTEMLPB1995-02-09
58011122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
58011528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
2303691528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
58012068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58252068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58011930080001P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADSNVN1986-07-29
58011832008425P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGNVN1986-07-29
58011112783194P820003VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATORLWP1982-11-16
58011716308144P240036OmniaSecure™ MRI SureScan™ Lead Model 3930MNVY2025-04-22
3142931157955820P240013Sphere-9 Catheter and Affera Ablation SystemQZI2024-10-24
58011157955820P240013Sphere-9 Catheter and Affera Ablation SystemQZI2024-10-24
58011790726095P230017PulseSelect™ Pulsed Field Ablation (PFA) systemQZI2023-12-13
58011716070735P220012Aurora EV-ICD SystemLWS2023-10-20
58011906758717P200028DiamondTemp Ablation SystemOAE2021-01-28
2303691906758717P200028DiamondTemp Ablation SystemOAE2021-01-28
58011912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
58012026924788P100047HEARTWARE VENTRICULAR ASSIST SYSTEMDSQ2012-11-20
58011814031394P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE2010-12-17
58011410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
58011991560562P080006MEDTRONIC ATTAIN ABILITY MODEL 4196 LEADOJX2009-04-07
58011510657756P030036MEDTRONIC SELECTSECURE LEAD MODEL 3830NVN2005-08-03
58011734968408P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEMLPB2003-04-17
58012051129662P010031CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONNIK2002-06-26
58011950599349P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMLWP2001-08-28
58011172382298K994331REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATORMXC2000-01-21
58011703825993K982220MODEL 2872 BIPOLAR LEAD ADAPTOR KITDTD1998-10-15
58011216172892K981642STABLEMAPR STEERABLE INTRACARDIAC CATHETERSDRF1998-08-05
58011426039027K973360MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEADLDF1998-05-26
58011511426953K971474MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOLDTE1997-07-14
58011486162022K965167PERCUTANEOUS VENOUS INTRODUCER 10264DYB1997-07-25
58011064959921K960446MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIESDSA1996-05-22
2303691086761684K960356POSTERIOR ANNULOPLASTY BAND (MODEL 607)KRH1996-08-27
58011963363442K953185PLATINUM SERIES EP DIAGNOSTIC CATHETERSDRF1996-04-15
58011642775941K951347MARINR SERIES EP DIAGNOSTI CATHETERSDRF1995-05-10
58011828422995K951313MEDAMICUS PERCUTANEOUS INTRODUCERDYB1995-06-27
58011940396456K931794MARINR SERIES EP DIAGNOSTIC CATHETERSDRF1994-06-06
58011594229790K923915TORQR SERIES DIAGNOSTIC EP CATHETERSDRF1993-02-10
58011971286564K923407MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLESLDF1992-10-19
58011960680680K915724MODEL 6984M LEAD EXTENDER KITDTD1992-02-18
58011333683372K915563DIAGNOSTIC EP CATHETERDRF1992-03-09
58011623681438K914460MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLESDRF1991-11-22
58011776204442K911827MODEL 5866-9M & MODEL 6981MDTD1991-07-23
58012055682424K911302MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KITDTD1991-07-30
58011601702415K911236MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLSDYB1991-06-18
58011812701629K904575MODEL 5866-37M LEAD ADAPTOR KITDTD1991-02-01
58011748721375K900515MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)DYB1990-08-23
58011817065357K885101MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTORDSA1989-01-12
58011453520079K880738MODEL 2331T PATIENT PROGRAMMERKRG1988-11-17
58011159797875K861368MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATORJOQ1986-08-04
58011570834946K854559MEDTRONIC PERMANENT LEAD INTRODUCERDYB1985-12-24
58011725521296K851091MEDTRONIC MODEL 5328 PROGRAM-STIMULATORJOQ1985-04-16
58011643426200K843718PROGRAMMABLE STIMULATOR 5326JOQ1984-09-27
58011609576562K833421PROGRAMMABLE STIMULATOR 2352JOQ1984-01-30
58011899144581K801284LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)DTB1980-12-01
58011284105121K253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)DQY2025-12-19
58011909688593K250558SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)DQY2025-03-27
58011981896487K243892Affera Integrated Mapping SystemDQK2025-01-17
58011131507260K243435Magnetic Localization Patch Kit (AFR-00021)DQK2024-12-05
58011195680740K241828Affera Integrated Mapping System; Impedance Localization Patch KitDQK2024-11-01
58012066997381K240693LINQ II™ Insertable Cardiac Monitor (ICM)MXD2024-03-28
3142931017396659K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)DQK2024-03-08
58011017396659K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)DQK2024-03-08
58011335594643K233691FlexCath Cross Transseptal SolutionDYB2023-12-17
58011579154164K233562LINQ II Insertable Cardiac MonitorMXD2023-12-06
58011410864382K233397Cosine-10TM Diagnostic CatheterDRF2023-12-02
58011221331976K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)MXD2023-10-31
2737781221331976K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)MXD2023-10-31
58011947743706K232321FlexCath Contour™ Steerable SheathDRA2023-10-31
58011484672501K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMXD2023-04-26
58011045404760K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification SystemMXD2023-04-05
58011640107660K221962LINQ II Insertable Cardiac MonitorMXD2022-08-25
58011733082690K220047AcQCross Qx Integrated Transseptal Dilator/NeedleDYB2022-02-08
58011305795452K212008Reveal LINQ Insertable Cardiac MonitorMXD2021-07-22
58011821575444K211304LINQ II Insertable Cardiac MonitorMXD2021-05-28
2737781821575444K211304LINQ II Insertable Cardiac MonitorMXD2021-05-28
58011340753667K210685AcQCross Qx Integrated Transseptal Dilator/NeedleDYB2021-04-06
58011342120416K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMXD2021-06-11
58011451279729K203556Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesDSA2021-07-12
58011272830836K202620FlexCath Advance Steerable Sheath and DilatorDRA2020-11-13
58011930433962K201011Medtronic Model 5392 External Pulse Generator (EPG)DTE2020-05-13
2303691930433962K201011Medtronic Model 5392 External Pulse Generator (EPG)DTE2020-05-13
58011140411658K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMXD2020-07-03
2737781140411658K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMXD2020-07-03
2303691140411658K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMXD2020-07-03
58011445211045K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery CatheterDQY2020-08-03
2303691252274755K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)FTL2020-04-08
58011252274755K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)FTL2020-04-08
58012058363615K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)FTL2020-03-27
2303692058363615K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)FTL2020-03-27
58011151434540K190825Medtronic Model 5392 External Pulse Generator (EPG)DTE2019-04-30
2303691151434540K190825Medtronic Model 5392 External Pulse Generator (EPG)DTE2019-04-30
58011571494419K190574Patient Assistant Model PA97000DSI2019-09-24
58011421158491K190132Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode CatheterDRF2019-07-30
58011856059692K183547Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode CatheterDRF2019-07-30
58011315996195K183493SelectSite C304-HIS Deflectable Catheter SystemDQY2019-03-15
58011649754675K183174FlexCath Advance Steerable Sheath and DilatorDRA2018-11-26
58011255026624K181973Medtronic Model 5392 External Pulse Generator (EPG)DTE2018-08-21
2303691255026624K181973Medtronic Model 5392 External Pulse Generator (EPG)DTE2018-08-21
58011217920020K181918CardioInsight Cardiac Mapping SystemDQK2018-11-08
58011260532368K180873Medtronic Model 53401 External Pulse Generator (EPG)DTE2018-04-19
58251260532368K180873Medtronic Model 53401 External Pulse Generator (EPG)DTE2018-04-19
2303691260532368K180873Medtronic Model 53401 External Pulse Generator (EPG)DTE2018-04-19
58011324139944K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)FTL2018-06-07
2303691324139944K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)FTL2018-06-07
58012028102594K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)FTL2018-04-24
2303692028102594K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)FTL2018-04-24
58011694201684K163460Reveal LINQ Insertable Cardiac MonitorMXD2017-02-14
58011238498119K163268FlexCath Select Steerable Shealth and DilatorDYB2017-02-02
58011420858541K163008CareLink SmartSync Device Manager - Pacing System AnalyzerDTA2017-02-28
58011064677602K162892Achieve Advance Mapping CatheterDRF2016-11-15
58011034028075K162550Medtronic Model 5392 External Pulse Generator (EPG)DTE2016-10-12
58251034028075K162550Medtronic Model 5392 External Pulse Generator (EPG)DTE2016-10-12
2303691034028075K162550Medtronic Model 5392 External Pulse Generator (EPG)DTE2016-10-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTE202020-05-13
MXD192024-03-28
DRF132023-12-02
FTL122020-04-08
DYB112023-12-17
DQY92025-12-19
DQK92025-01-17
DTD72013-07-30
DRA62023-10-31
DSI42019-09-24
KRH42006-05-23
NVN42005-08-03
LWS42000-06-14
NVZ41999-01-29
JOQ41986-08-04
DSA32021-07-12
LWP32011-02-08
LDF32004-09-07
OAE 22021-01-28
LPB22003-04-17
DTA12017-02-28
PNJ12016-04-06
DQX12015-03-11
QYX12014-02-06
DSQ12012-11-20
KRE12011-06-08
OAE12010-12-17
OJX12009-04-07
DTL12006-01-11
DPS12003-05-29
DWS12002-10-09
NIK12002-06-26
DYG12001-08-28
MXC12000-01-21
NVY11993-12-09
KRG11988-11-17
DTB11980-12-01

PMA#

200 records. Showing 1-40. Next

PMN#

95 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next