FDA.reportPublic FDA data

MEDTRONIC, INC.

Matched from indexed company URL: MEDTRONIC,INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10304891000477302MEDTRONIC SOFAMOR DANEK USA, INC.1Y2026-01-011800 PYRAMID PLACE Memphis TN US 38132
10452541045254MEDTRONIC XOMED, INC.1N2026-01-016743 SOUTHPOINT DR. NORTH Jacksonville FL US 32216
12190711000159144MEDTRONIC XOMED, INC.1N2026-01-01950 Flanders Rd Mystic CT US 06355
12204521220452MEDTRONIC VASCULAR1N2026-01-0137A Cherry Hill Dr DANVERS MA US 01923
16255071625507MEDTRONIC POWERED SURGICAL SOLUTIONS1Y2026-01-014620 NORTH BEACH ST. FORT WORTH TX US 76137
17183891718389MEDTRONIC PERFUSION SYSTEMS1N2026-01-0118501 E Plaza Dr PARKER CO US 80134
17231701000517638MEDTRONIC NAVIGATION, INC.1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
20255872025587Medtronic Heart Valves Division1N2026-01-011851 EAST DEERE AVE. Santa Ana CA US 92705
20322273003166194MEDTRONIC MINIMED1N2026-01-0118000 Devonshire St NORTHRIDGE CA US 91325
21822072182207MEDTRONIC NEUROMODULATION1N2026-01-017000 Central Ave., N.E. Minneapolis MN US 55432
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
21840091000116158MEDTRONIC PERFUSION SYSTEMS1N2026-01-017611 Northland Dr Minneapolis MN US 55428
26473462647346MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO1Y2026-01-01ROAD 909, KM. 0.4. BARRIO MARIANA HUMACAO PR US 00792
26496222649622MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA1N2026-01-01RD. 149, KM. 56.3 Call Box 6001 Villalba PR US 00766
29532003001452571Medtronic Vascular1N2026-01-013576 Unocal Pl Santa Rosa CA US 95403
96113501000241540MEDTRONIC FABRICATION S.A.S.1N2026-01-01103 ROUTE D ANOR FOURMIES Nord FR 59610
30015049943001504994Medtronic, Inc.1Y2026-01-01710 Medtronic Parkway Minneapolis MN US 55432
30028075613002807561MEDTRONIC B.V. (EOC)1N2026-01-01EARL BAKKENSTRAAT 10 HEERLEN Limburg NL 6422 PJ
30031208973003120897MEDTRONIC SOFAMOR DANEK USA, INC.1N2026-01-014340 Swinnea Road Memphis TN US 38118
30032761513003276151Medtronic Bakken Research Center B.V. (BRC)1N2026-01-01Endepolsdomein 5 Maastricht Limburg NL 6229 GW
30039553073003955307Medtronic Grand Rapids1N2026-01-01620 Watson SW Grand Rapids MI US 49504
30041857813004185781Medtronic, Inc.1N2026-01-012343 W. Medtronic Way Tempe AZ US 85281
30042091783004369318MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS1N2026-01-01ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK Juncos PR US 00777
30045942673004594267Medtronic Care Management Services1N2026-01-01200 Medtronic Dr Lafayette CO US 80026

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
00199150002375MiniMed App - SW MMT-8098 CONTROLLER APP IOS V1.0.0+1(800)633-8766Corporate.UDI@medtronic.com
00199150002382MiniMed App - SW MMT-8099 CONTROLLER APP ANDROID 1.0.0+1(800)633-8766Corporate.UDI@medtronic.com
00199150071807Medtronic Reusable Instruments - RETRACTOR EX0226090 20X90 SLOTED BEVL TB+1(800)633-8766Corporate.UDI@medtronic.com
00199150071814Medtronic Reusable Instruments - RETRACTOR EX0226100 20X100 SLOTED BVL TB+1(800)633-8766Corporate.UDI@medtronic.com
00199150073504Medtronic Reusable Instruments - GRAFT PLUNGER EX1225001 BONE+1(800)633-8766Corporate.UDI@medtronic.com
00199150077380MiniMed Flex - PUMP MMT-8062 Flex FOTA SW1.2.0 US+1(800)633-8766Corporate.UDI@medtronic.com
00613994964120Sones™ Brachial - WVN CATH 990707 10PK 8F SONES BRAC 100CM+1(800)633-8766Corporate.UDI@medtronic.com
00613994964748Goodale-Lubin™ - WVN CATH 007460 10PK 5520 7 125 GOODLUBN+1(800)633-8766Corporate.UDI@medtronic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58211512206475P990064MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVEDYE2000-07-14
58211242148943P990046ATS OPEN PIVOT BILEAFLET HEART VALVELWQ2000-10-13
1028641382056634P990034MEDTRONIC ISOMED INFUSION SYSTEMLKK2000-07-21
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
58041877254910P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS2000-06-14
58071877254910P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS2000-06-14
58211092786922P980043HANCOCK II PORCINE BIOPROSTHESISDYE1999-09-28
57621232151429P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
58011232151429P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
58071232151429P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
58071119875627P980022CONTINUOUS GLUCOSE MONITORING SYSTEMMDS1999-06-15
3445321119875627P980022CONTINUOUS GLUCOSE MONITORING SYSTEMMDS1999-06-15
57621178418077P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS1998-10-09
58011178418077P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS1998-10-09
58071178418077P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS1998-10-09
58211180504177P970031MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESISLWR1997-11-26
57611954472080P970015INTER FIX THREADED FUSION DEVICEMAX1999-05-14
58011925563044P970012MEDTRONIC.KAPPA 400 SERIES PACEMAKERSNVZ1998-01-30
58071925563044P970012MEDTRONIC.KAPPA 400 SERIES PACEMAKERSNVZ1998-01-30
57621865359843P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
58041865359843P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
58071865359843P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
1028641865359843P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
1028641423819233P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY1997-07-31
57621423819233P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY1997-07-31
58041423819233P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY1997-07-31
58071423819233P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY1997-07-31
58041517373177P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695NVN1996-09-06
58011620496774P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568NVN1996-03-29
58041620496774P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568NVN1996-03-29
58011317666566P930029ATAKR(TM) RFCA SYSTEMLPB1995-02-09
58041317666566P930029ATAKR(TM) RFCA SYSTEMLPB1995-02-09
57621122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
58011122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
58041122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
58051122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
3236481122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
58011528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
58041528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
58071528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
57622068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58012068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58042068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58072068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58211126182353P870078HANCOCK PORCINE BIOPROSTHESISDYE1989-09-28
1028641458099229P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMLKK1988-03-14
57621458099229P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMLKK1988-03-14
58071458099229P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMLKK1988-03-14
58011930080001P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADSNVN1986-07-29
58041930080001P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADSNVN1986-07-29
57621747154182P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW1984-11-30
58041747154182P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW1984-11-30
58071747154182P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW1984-11-30
1028641747154182P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW1984-11-30
58011832008425P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGNVN1986-07-29
58041832008425P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGNVN1986-07-29
57591230296185P820075LAMICEL(TM)LOB1983-06-21
57621112783194P820003VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATORLWP1982-11-16
58011112783194P820003VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATORLWP1982-11-16
58211974486763P790007HANCOCK MODIFIED ORIFICE BIOPROSTHESISLWR1979-11-15
3445321071781734P250012Simplera Sync Sensor, Guardian 4 SensorSFI2025-08-06
58011716308144P240036OmniaSecure™ MRI SureScan™ Lead Model 3930MNVY2025-04-22
58041716308144P240036OmniaSecure™ MRI SureScan™ Lead Model 3930MNVY2025-04-22
58011157955820P240013Sphere-9 Catheter and Affera Ablation SystemQZI2024-10-24
57621282547309P240011Medtronic Altaviva SystemQPT2025-09-18
58071282547309P240011Medtronic Altaviva SystemQPT2025-09-18
1028641282547309P240011Medtronic Altaviva SystemQPT2025-09-18
58011790726095P230017PulseSelect™ Pulsed Field Ablation (PFA) systemQZI2023-12-13
58151366141209P220026Symplicity Spyral™ Renal Denervation SystemQYI2023-11-17
57621716070735P220012Aurora EV-ICD SystemLWS2023-10-20
58011716070735P220012Aurora EV-ICD SystemLWS2023-10-20
58041716070735P220012Aurora EV-ICD SystemLWS2023-10-20
58211091031584P200046Harmony™ TPV SystemNPV2021-03-26
58011906758717P200028DiamondTemp Ablation SystemOAE2021-01-28
522581182749620P200026Abre Venous Self-expanding Stent SystemQAN2020-10-21
58151840090773P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterPRC2019-11-21
58211544873900P170006AVALUS(TM) BIOPROSTHESISLWR2017-07-31
58151509855441P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2017-04-28
57921509855441P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2017-04-28
3445321929078790P160017MiniMed 670G SystemOZP2016-09-28
3445321585303107P160007Guardian Connect systemMDS2018-03-08
57621912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
58011912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
3445321318279110P150029IPRO2 CGM SYSTEM WITH ENLITE SENSORMDS2016-06-17
3445321445479726P150019PARADIGM REAL-TIME REVEL SYSTEMMDS2015-12-07
3445321530536895P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
522581016057609P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
58051016057609P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
522581502379501P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
58211150969043P140017MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)NPV2015-01-27
58152046408222P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU2014-12-30
58211343864551P130021MEDTRONIC COREVALVE SYSTEMNPT2014-01-17
58071369736154P130008INSPIRE II UPPER AIRWAY STIMULATORMNQ2014-04-30
58041634297319P120017MODEL 5071 LEADDTB2015-04-27
58071401008520P120010MINIMED 530G SYSTEMOZO2013-09-26
3445321401008520P120010MINIMED 530G SYSTEMOZO2013-09-26
522581495882358P110023EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)NIP2012-03-07
58151715533001P110013RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2012-02-17
57921715533001P110013RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2012-02-17
58012026924788P100047HEARTWARE VENTRICULAR ASSIST SYSTEMDSQ2012-11-20
57921598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
58151598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
58151783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
57921783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
58011814031394P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE2010-12-17
58041814031394P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE2010-12-17
57611520450386P090029PRESTIGE LP CERVICAL DISCMJO2014-07-24
57621520450386P090029PRESTIGE LP CERVICAL DISCMJO2014-07-24
58111520450386P090029PRESTIGE LP CERVICAL DISCMJO2014-07-24
57621410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
58011410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
58041410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
58071410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
57621971537090P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON2011-03-14
58041971537090P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON2011-03-14
58071971537090P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON2011-03-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB2032026-04-21
KWP1652013-04-01
DWF1192026-01-20
MAX1102022-04-12
KWQ892015-11-12
MQP712019-04-04
GEI672024-02-28
HAW612026-03-26
OLO552026-02-12
MNI552006-12-22
DQY532025-12-19
MNH532006-07-25
HRX352015-07-23
LIT272021-12-15
DTZ252024-07-10
LDF252019-08-08
DQX242025-06-13
DRF242023-12-02
ODP232019-08-16
FGE232008-03-18
OVD222024-10-28
ETN202026-02-10
DYB202023-12-17
DTN202017-03-17
OCL182022-12-22
MCW182021-08-24
MXD172024-03-28
OVE172019-08-06
HBE162021-11-23
KRH162020-07-01
NDN142022-04-18
OTD142018-11-21
MQV142015-08-14
NKG132026-01-21
NQP132021-01-15
FTL132020-04-08
ERL132015-08-14
JOX132011-06-08
DTM122026-01-16
GZB122010-10-26

PMA#

Consulta CRT-P, Syncra CRT-P

2023-02-03

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS513 Date Received01/23/2023 Decision Date02/03/2023 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG

2023-02-03

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS739 Date Received01/23/2023 Decision Date02/03/2023 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

Restore and Itrel® Spinal Cord Stimulation Systems

2023-02-02

MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS536 Date Received01/20/2023 Decision Date02/02/2023 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...

Activa® Deep Brain Stimulation Therapy System

2023-02-02

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS446 Date Received01/20/2023 Decision Date02/02/2023 Product Code MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...

HeartWare® Ventricular Assist System, HeartWare® System

2023-02-02

Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS205 Date Received01/19/2023 Decision Date02/02/2023 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - ...

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...

Arctic Front Advance® Cardiac CryoAblation Catheters

2023-01-19

Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS134 Date Received12/21/2022 Decision Date01/19/2023 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reaso...

9F Freezor MAX Cardiac Cryoablation Catheter

2023-01-19

Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS135 Date Received12/22/2022 Decision Date01/19/2023 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reaso...

Sprint Quattro Lead

2023-01-16

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS274 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

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...

CapSure Sense Lead

2023-01-16

MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP830061 Supplement NumberS211 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Noti...

MiniMed 630G System

2022-12-16

MEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150001 Supplement NumberS102 Date Received11/16/2022 Decision Date12/16/2022 Product Code OZO  Advisory Committee Clinical Chemistry Supplement Typespecial (immediate Track) Supplement Reas...

MiniMed 670G System, MiniMedTM 770G System

2022-12-16

MEDTRONIC MINIMED, INC.18000 Devonshire Streetnorthridge, CA 91325 PMA NumberP160017 Supplement NumberS106 Date Received11/16/2022 Decision Date12/16/2022 Product Code OZP  Advisory Committee Clinical Chemistry Supplement Typespecial (immediate Track) Suppl...

Micra AV TPS, Micra TPS

2022-12-12

MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS164 Date Received12/06/2022 Decision Date12/12/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...

InterStim® Therapy System, Verify® Evaluation System (SNS Bowel)

2022-12-08

MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS273 Date Received11/23/2022 Decision Date12/08/2022 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...

SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

2022-12-08

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS403 Date Received11/23/2022 Decision Date12/08/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Proce...

InterStim® Therapy System, Verify® Evaluation System (SNS Urinary)

2022-12-08

MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS378 Date Received11/23/2022 Decision Date12/08/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...

Guardian Connect System

2022-12-08

MEDTRONIC MINIMED18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP160007 Supplement NumberS046 Date Received11/04/2022 Decision Date12/08/2022 Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - M...

MiniMed Enlite Sensor

2022-12-08

MEDTRONIC Inc.18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP120010 Supplement NumberS142 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Pro...

SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

2022-12-02

MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS402 Date Received11/07/2022 Decision Date12/02/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Proce...

Medtronic CoreValve Evolut FX System

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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...

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