FDA.report

MEDTRONIC, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
21822082182208MEDTRONIC, INC.1N2026-01-018200 Coral Sea Street NE Mounds View MN US 55112
21838702183870Medtronic, Inc.1N2026-01-014600 Nathan Lane North Plymouth MN US 55442
30015049943001504994Medtronic, Inc.1Y2026-01-01710 Medtronic Parkway Minneapolis MN US 55432
30041857813004185781Medtronic, Inc.1N2026-01-012343 W. Medtronic Way Tempe AZ US 85281
30085925443008592544Medtronic, Inc. (Minneapolis, MN 55447)1N2026-01-013800 ANNAPOLIS LANE Minneapolis MN US 55447
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

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1272931242148943P990046ATS OPEN PIVOT BILEAFLET HEART VALVELWQ2000-10-13
58011309515697P9900011969-12-31
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
2303691528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
58011528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
58252068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58012068263149P890003SYNERGYST 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
58011716308144P2400361969-12-31
3142931157955820P2400131969-12-31
58011157955820P2400131969-12-31
58011790726095P2300171969-12-31
58011716070735P2200121969-12-31
2303691906758717P200028DiamondTemp Ablation SystemOAE 2021-01-28
58011906758717P200028DiamondTemp Ablation SystemOAE 2021-01-28
522581182749620P200026Abre Venous Self-expanding Stent SystemQAN 2020-10-21
58011912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
522581016057609P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
522581502379501P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
522581495882358P110023EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)NIP2012-03-07
522581495882358P110023EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)NIP2012-03-07
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
522581379074213P060001PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMSNIM2007-01-24
522581379074213P060001PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMSNIM2007-01-24
522581312948322P030045INTRASTENT DOUBLESTRUT STENTNIO2004-06-08
522581312948322P030045INTRASTENT DOUBLESTRUT STENTNIO2004-06-08
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
522582062783362P000033
58011172382298K994331REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATORMXC2000-01-21
522581460448131K993904INTRASTENT DOUBLESTRUT LDFGE2000-02-01
522581460448131K993904INTRASTENT DOUBLESTRUT LDFGE2000-02-01
522581076267006K992816MODIFICATION TO INTRASTENTFGE1999-10-15
522581972217953K990592INTRASTENT IIFGE1999-09-01
522581128923576K982657AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100MCW1998-11-18
58011703825993K982220MODEL 2872 BIPOLAR LEAD ADAPTOR KITDTD1998-10-15
58011216172892K981642STABLEMAPR STEERABLE INTRACARDIAC CATHETERSDRF1998-08-05
58011426039027K973360MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEADLDF1998-05-26
522581171003132K972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETERDXE1998-03-06
522581171003132K972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETERDXE1998-03-06
58011511426953K971474MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOLDTE1997-07-14
522581614153845K970668THE AMPLANTZ GOOSE NECK MICROSNAREDQY1998-06-10
522581614153845K970668THE AMPLANTZ GOOSE NECK MICROSNAREDQY1998-06-10
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
522581732452758K914046THE BIG EASY Y-ADAPTERDYB1991-11-08
522581732452758K914046THE BIG EASY Y-ADAPTERDYB1991-11-08
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
522581174102335K895899FLEXMEDICS GUIDEWIRE .012 ONLYDQX1990-05-23
522581174102335K895899FLEXMEDICS GUIDEWIRE .012 ONLYDQX1990-05-23
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
522582067533228K241259Amplatz Goose Neck Snare KitMMX2024-06-03
58012066997381K240693LINQ II™ Insertable Cardiac Monitor (ICM)MXD2024-03-28
58011017396659K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)DQK2024-03-08
3142931017396659K233943Affera 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
2737781221331976K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)MXD2023-10-31
58011221331976K233320LINQ 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
522581922414013K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterGEI2023-03-23
58011640107660K221962LINQ II Insertable Cardiac MonitorMXD2022-08-25
58011733082690K220047AcQCross Qx Integrated Transseptal Dilator/NeedleDYB2022-02-08
522581430055291K213631Chocolate PTA Balloon CatheterLIT2021-12-15
522581385785360K212027TurboHawk Plus Directional Atherectomy SystemMCW2021-08-24
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
522581419553286K202800Pacific Plus PTA CatheterLIT2020-11-18
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
2303691140411658K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMXD2020-07-03
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

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQY282025-12-19
LIT242021-12-15
FGE232008-03-18
DTE202020-05-13
MXD192024-03-28
MCW182021-08-24
DQX152015-03-11
DYB132023-12-17
DRF132023-12-02
FTL122020-04-08
GEI112023-03-23
DQK92025-01-17
DTD72013-07-30
DRA62023-10-31
NTE52011-10-27
OCL42019-10-01
DSI42019-09-24
KRD42015-04-22
KRH42006-05-23
NVN42005-08-03
LWS42000-06-14
NVZ41999-01-29
JOQ41986-08-04
DSA32021-07-12
LWP32011-02-08
QEZ32008-03-04
LDF32004-09-07
OAE 22021-01-28
PJQ22015-02-20
PDU22012-05-22
NIP22012-03-07
NIM22007-01-24
NFA22007-01-19
NIO22004-06-08
LPB22003-04-17
DXE21998-03-06
MMX12024-06-03
QAN 12020-10-21
DPW12020-01-10
DWF12017-06-02

PMA

Evolut FX Delivery Catheter System

2023-01-29

Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS131 Date Received01/27/2023 Decision Date01/29/2023 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

CapSureFix Novus Lead

2023-01-16

Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS248 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Medtronic CoreValve Evolut FX System

2022-12-01

Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS129 Date Received11/30/2022 Decision Date12/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

Harmony Delivery Catheter System

2022-12-01

Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS013 Date Received11/29/2022 Decision Date12/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

CapSure VDD-2 Lead and Vitatron Brilliant S+ VDD Lead

2022-11-22

Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP890003 Supplement NumberS458 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Harmony™ Delivery Catheter System

2022-11-01

Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

CapSureFix Novus Lead

2022-10-25

Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS246 Date Received10/19/2022 Decision Date10/25/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

2022-09-15

Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS245 Date Received09/13/2022 Decision Date09/15/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Medtronic Evolut FX Delivery Catheter and Loading Systems

2022-09-09

Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS121 Date Received09/06/2022 Decision Date09/09/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

CapSureFix Novus MRI SureScan Lead Models 4076 and 5076

2022-08-26

Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS244 Date Received06/17/2022 Decision Date08/26/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supple...

Harmony™ Transcatheter Pulmonary Valve

2022-07-27

Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS011 Date Received07/26/2022 Decision Date07/27/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

PMN

Applications

GUDID

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2026-03-22

MEDTRONIC, INC.

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MEDTRONIC, INC.

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MEDTRONIC, INC.

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MEDTRONIC, INC.

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2026-03-22

MEDTRONIC, INC.

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2026-03-22

MEDTRONIC, INC.

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2026-03-22

MEDTRONIC, INC.

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2026-03-22

MEDTRONIC, INC.

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2026-03-22

MEDTRONIC, INC.