FDA.reportPublic FDA data

Medtronic Distribution Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30093800633009380063Medtronic Distribution Center1N2026-01-015300 Airways Blvd Memphis TN US 38116

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1352651877254910P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS2000-06-14
1352651232151429P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
1352651178418077P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS1998-10-09
1352651865359843P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
1352651423819233P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY1997-07-31
1352651517373177P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695NVN1996-09-06
1352651620496774P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568NVN1996-03-29
1352651122921662P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY1993-12-09
1352651528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
1352652068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
1352651930080001P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADSNVN1986-07-29
1352651747154182P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW1984-11-30
1352651832008425P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGNVN1986-07-29
1352651716308144P240036OmniaSecure™ MRI SureScan™ Lead Model 3930MNVY2025-04-22
1352651716070735P220012Aurora EV-ICD SystemLWS2023-10-20
1352651182749620P200026Abre Venous Self-expanding Stent SystemQAN2020-10-21
1352651509855441P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2017-04-28
1352651912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
1352652046408222P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU2014-12-30
1352651343864551P130021MEDTRONIC COREVALVE SYSTEMNPT2014-01-17
1352651634297319P120017MODEL 5071 LEADDTB2015-04-27
1352651598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
1352651783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
1352651881882229P100018PIPELINE EMBOLIZATION DEVICEOUT2011-04-06
1352651963636847P100018PIPELINE EMBOLIZATION DEVICEOUT2011-04-06
1352651410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
1352651971537090P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON2011-03-14
1352651991560562P080006MEDTRONIC ATTAIN ABILITY MODEL 4196 LEADOJX2009-04-07
1352651435292421P060039ATTAIN STARFIX MODEL 4195 LEADOJX2008-06-13
1352651510657756P030036MEDTRONIC SELECTSECURE LEAD MODEL 3830NVN2005-08-03
1352651025546535P030004ONYX LIQUID EMBOLIC SYSTEMMFE2005-07-21
1352651276958147P030004ONYX LIQUID EMBOLIC SYSTEMMFE2005-07-21
1352652051129662P010031CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONNIK2002-06-26
1352651950599349P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMLWP2001-08-28
1352651379164924K994171MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAEDWF2000-04-27
1352651940944722K993677MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNTDWF2000-04-17
1352651837660933K991066MADTRONIC DLP ARTERIAL CANNULAEDWF1999-09-14
1352651289344868K982532PARIETEXFTL1999-01-20
1352651197636810K980915VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEMFYD1998-06-29
1352651576003066K973011BPX80 BIO-PUMP (BPX80)KFM1998-02-25
1352651318106377K963253SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1996-10-08
1352651915319561K963115TROCAR CANNULAGCJ1997-02-12
1352651288181564K961940INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEPGCJ1996-07-10
1352651950216771K961771AUTO SUTURE SURGIWANDGEI1996-09-25
1352651007889689K955836VALLEYLAB COATED ELECTRODESGEI1996-02-01
1352651017708071K954853AUTO SUTURE SUTURE CLOSUREGCJ1995-12-20
1352651538148101K954108MODIFIED VERSAPORTGCJ1995-10-17
1352651425839395K954020MICRO THERAPEUTICS SIDEHOLE INFUSION WIREKRA1996-01-02
1352651006829122K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETDWF1996-03-26
1352651712301150K952977SABRE MULTI-USE TROCAR SYSTEMGCJ1995-07-17
1352651038005327K951589MANUAL SURGICAL INSRUMENTGEI1995-05-03
1352651980832994K946002ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRAGEX1995-01-05
1352651601609171K940634MICRO THERAPEUTICS INFUSION CATHETERFOZ1994-10-14
1352651511777084K935086AUTO SUTURE DISPOSABLE OPTICAL TROCARGCJ1994-02-17
1352651216155940K934738AUTOSUTURE ENDOSCOPIC SUTURING DEVICEOCW1994-03-16
1352651298635699K924643MEDTRONIC BIO-MEDICUS CANNULA INSERTION KITDWF1992-12-08
1352651577251745K924642MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCERDWF1993-03-26
1352651780692306K924529SIGNATURE(TM) CUSTOM TUBING PACKDWF1993-06-23
1352651035398406K924011ORIGIN BLUNT TIP SURGICAL TROCARGCJ1993-07-09
1352652068667968K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHGCI1993-02-01
1352651960680680K915724MODEL 6984M LEAD EXTENDER KITDTD1992-02-18
1352652017364315K915268CATHETER TWO STAGE VENOUS RETURNDWF1992-07-27
1352651240379712K914190AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTORGAD1992-05-06
1352651776204442K911827MODEL 5866-9M & MODEL 6981MDTD1991-07-23
1352652055682424K911302MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KITDTD1991-07-30
1352651104307659K904588AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOPGAL1990-12-24
1352651872536108K904560VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODESGEI1990-12-31
1352651136744389K903419MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVEGDH1990-08-09
1352651852476872K903206AUTO SUTURE(R) ENDOSCOPIC SCISSORSHET1990-10-17
1352651338528599K903205AUTO SUTURE(R) ENDOSCOPIC CLAMPHDA1990-10-11
1352651366715303K901074CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULADWF1990-07-06
1352652038628930K900129MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*GDW1990-02-27
1352651825612749K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETDQY1988-12-21
1352651933898522K875353PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KITDWF1988-03-22
1352651149064101K872033BIO-MEDICUS CANNULA-TUBINGDWF1987-12-07
1352651148978549K865079ASPIRATING NEEDLE, CATALOG CODE #12006DWF1987-03-03
1352651888892973K863330DISPOSABLE PNEUMOPERITONEUM NEEDLEFHO1986-10-02
1352651946844382K860149VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015DWF1986-03-31
1352651709422085K854487VENOUS RETURN CANNULA W/CUFF 91039DWF1986-02-10
1352651658538014K850385INTRACARDIAC SUMP 12010DWF1985-04-29
1352651674067141K845046PUL,MONARY ARTERY VENT CATHETERDWF1985-04-03
1352651374451394K845045VENOUS RETURN CATHETER SS-1DWF1985-04-03
1352651024554522K842375VENOUS CANNULA W/BENT, TIP WIREDWF1984-08-10
1352651279658210K841482PRESSURE CATHETER PLACEMENT SET 50010DWF1984-06-11
1352651119923243K840002ARTERIAL CANNULA CURVED BEVELED TIPDWF1984-02-13
1352651130204206K840001ARTERIAL CANNULA STRAIGHT BEVELED TIPDWF1984-02-13
1352651829274315K834039INFANT VENT CATHETER 12001 W/SIDE VENTDWF1984-01-03
1352651992637877K831591AORTIC ROOT CANNULA W/INTEGRAL PRESSDWF1983-06-30
1352651867758360K830735BT 795/A AUTOTRANSCAC1983-05-02
1352652018349973K822572POLYHESIVE PATIENT RETURN ELECTRODEGEI1982-09-21
1352651953943598K821149SUBMISSION CORONARY CANNULADWF1982-05-18
1352651950001529K813071E2508 DISPOSABLE HANDSWITCHING PENCILGEI1981-11-10
1352651783177253K810820CARDIOPULMONARY BYPASSDWF1981-04-03
1352651935300786K810548CARDIOPULMINARY BYPASS CATHETER CANNULADWF1981-03-17
1352651416146925K800178EXTRACORP.'S INTERSEPT CUS. TUBING PK.DWE1980-02-21
1352651727112905K791832VEIN GRAFT CANNULADWF1979-10-04
1352652072018451K791498ADAPTER-Y TYPE/CORONARY PERFUSIONDTL1979-08-28
1352651201825067K790565AORTIC ROOT CANNULADWF1979-06-11
1352651003652895K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemNKB2026-04-21
1352651544475345K254165Infinity™ OCT SystemNKG2026-01-21
1352651847166865K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)NKB2026-01-07
1352651556565233K253129Infinity™ OCT SystemNKG2025-10-24
1352651785998478K250787Liberant Thrombectomy SystemQEW2025-06-11
1352651313692886K243007CD Horizon™ Spinal SystemNKB2024-10-23
1352651838743937K241992Catalyft™ LS Expandable Interbody SystemOVD2024-10-28
1352652010453555K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)NKB2023-08-16
1352651500096948K231184CD Horizon™ Spinal SystemOLO2023-05-26
1352652042843099K230716Robotic Graft Delivery InstrumentsOLO2023-07-18
1352651906645057K223494CD Horizon Spinal SystemNKB2023-01-23
1352651750580087K221244CD Horizon™ Spinal SystemNKB2022-05-25
1352651821575444K211304LINQ II Insertable Cardiac MonitorMXD2021-05-28
1352651556161200K203358Solitaire X Revascularization DevicePOL2021-03-01
1352651597403886K202318Marathon Flow Directed Micro CatheterKRA2020-09-14
1352651140411658K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMXD2020-07-03
1352651981348534K192443Dextile Anatomical MeshFTL2019-12-06
1352651043235009K191565Endoskeleton TCS Interbody Fusion DeviceOVE2019-08-06
1352651876081027K183197PYRAMESH™ Implant SystemMQP2019-04-04
1352651671689062K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)NRY2018-12-18
1352651882649965K182957Heli-FX EndoAnchor SystemOTD2018-11-21
1352651417626370K181186Solitare Platinum Revascularization DevicePOL2018-10-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF482015-01-07
GCJ202017-03-08
GEI132018-03-02
NKB92026-04-21
NRY92018-12-18
GDW82018-02-20
OTD72018-11-21
HCG62017-01-03
KRA52020-09-14
FTL52019-12-06
MAX52017-10-05
NVN52005-08-03
MXD42021-05-28
POL42021-03-01
DQY42011-04-05
KRD42009-02-27
OLO32023-07-18
GAM32011-06-03
LWS32000-06-14
DTD31992-02-18
NKG22026-01-21
OVD22024-10-28
MQP22019-04-04
LFL22018-03-26
FZP22015-09-14
DTB22015-04-27
DQX22012-02-24
OUT22011-04-06
MIH22011-04-01
EZW22011-03-14
LWP22011-02-08
OCW22009-05-14
OJX22009-04-07
MFE22005-07-21
GAD22005-02-23
NVZ21999-01-29
QEW12025-06-11
QAN 12020-10-21
OVE12019-08-06
NIQ12017-04-28