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MEDTRONIC MINIMED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20322273003166194MEDTRONIC MINIMED1N2026-01-0118000 Devonshire St NORTHRIDGE CA US 91325
20322273003166194MEDTRONIC MINIMED1Y2020-04-2518000 Devonshire St NORTHRIDGE CA US 91325

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3445321119875627P980022CONTINUOUS GLUCOSE MONITORING SYSTEMMDS1999-06-15
1565991119875627P980022CONTINUOUS GLUCOSE MONITORING SYSTEMMDS1999-06-15
3445321071781734P250012Simplera Sync Sensor, Guardian 4 SensorSFI2025-08-06
1565991929078790P160017MiniMed 670G SystemOZP2016-09-28
3445321929078790P160017MiniMed 670G SystemOZP2016-09-28
1565991585303107P160007Guardian Connect systemMDS2018-03-08
3445321585303107P160007Guardian Connect systemMDS2018-03-08
1565991318279110P150029IPRO2 CGM SYSTEM WITH ENLITE SENSORMDS2016-06-17
3445321318279110P150029IPRO2 CGM SYSTEM WITH ENLITE SENSORMDS2016-06-17
1565991445479726P150019PARADIGM REAL-TIME REVEL SYSTEMMDS2015-12-07
3445321445479726P150019PARADIGM REAL-TIME REVEL SYSTEMMDS2015-12-07
1565991530536895P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
3445321530536895P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
1565991401008520P120010MINIMED 530G SYSTEMOZO2013-09-26
3445321401008520P120010MINIMED 530G SYSTEMOZO2013-09-26
1565991899331370K992300QUICK-SERTER, MODEL 395KZH1999-07-29
3445321899331370K992300QUICK-SERTER, MODEL 395KZH1999-07-29
3445321090840791K9919363.0 ML RESERVOIR, MODEL 103/193FRN2000-01-18
1565991430861873K9919363.0 ML RESERVOIR, MODEL 103/193FRN2000-01-18
1565992034012047K991759MAERSK MEDICAL CONTOUR INFUSION SETFPA1999-06-25
3445322034012047K991759MAERSK MEDICAL CONTOUR INFUSION SETFPA1999-06-25
1565991022082469K990801MINIMED 508 INSULIN PUMPLZG1999-06-08
3445321022082469K990801MINIMED 508 INSULIN PUMPLZG1999-06-08
1565991528245748K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SETFPA1997-08-26
3445321528245748K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SETFPA1997-08-26
1565991286179855K970479MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300KZH1997-03-31
3445321286179855K970479MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300KZH1997-03-31
3445321868769327K253743MiniMed Flex pumpQFG2026-03-12
3445321311013621K253701SmartGuard Technology; Predictive Low Glucose TechnologyQJI2026-02-03
3445321795085469K253585SmartGuard technology; Predictive Low Glucose technologyQJI2026-01-14
3445321038827179K253512MiniMed Go AppNDC2026-01-08
3445321535005838K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG2026-01-15
3445321424200186K251217SmartGuard technology; Predictive Low Glucose technologyQJI2025-08-29
3445321602879262K251032MiniMed 780G insulin pumpQFG2025-07-01
3445321680164816K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC2024-11-12
3445321988252957K210714Extended ReservoirLZG2022-04-06
3445321666631886K201337InPen SystemNDC2020-06-18
3445322013316681K192841InPen SystemNDC2020-02-10
3445321962717937K190487InPen Dose CalculatorNDC2020-02-18
3445322036896515K181327InPen Dose CalculatorNDC2018-07-06
1565991951108881K160860MiniMed Quick-serterKZH2016-09-22
3445321951108881K160860MiniMed Quick-serterKZH2016-09-22
3445321891690002K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA2016-08-10
3445321681766290K160629InPenFMF2016-07-26
1565992032214351K151236MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)PJT2015-05-19
3445322032214351K151236MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)PJT2015-05-19
1565991482446862K120206MEDTRONIC MINIMED PARADIGM INSULIN PUMPSLZG2012-03-29
3445321490395409K100432POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETSFPA2010-07-09
1565991490395409K100432POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETSFPA2010-07-09
1565991355712485K070438MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305MRZ2007-10-17
3445321355712485K070438MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305MRZ2007-10-17
1565991937013478K053177MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712ELZG2006-01-31
3445321937013478K053177MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712ELZG2006-01-31
1565992018477497K041545CONTACT DETACHFPA2004-06-30
3445322018477497K041545CONTACT DETACHFPA2004-06-30
1565991206759972K041318MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMPLZG2004-07-19
3445321206759972K041318MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMPLZG2004-07-19
3445321509981879K040676MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715LZG2004-05-21
1565991271796021K032854UNOMEDICAL MONICA INFUSION SETFPA2003-10-09
3445321271796021K032854UNOMEDICAL MONICA INFUSION SETFPA2003-10-09
3445321341029045K032005MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332FRN2003-08-22
1565991341029045K032005MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332FRN2003-08-22
1565991787898279K031541PARADIGMPAL, MODEL MMT-7330LZG2003-11-18
3445321787898279K031541PARADIGMPAL, MODEL MMT-7330LZG2003-11-18
1565991393943187K021974MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311MRZ2002-08-06
3445321393943187K021974MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311MRZ2002-08-06
1565992023902106K011071PARADIGM QUICK-SET INFUSION SETFPA2001-06-07
3445322023902106K011071PARADIGM QUICK-SET INFUSION SETFPA2001-06-07
1565991220818621K010377MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385KZH2001-04-05
3445321220818621K010377MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385KZH2001-04-05
1565991856586829K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380FPA2000-08-29
3445321856586829K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380FPA2000-08-29
1565991718296933K001829MINIMED PARADIGM INSULIN PUMP, MODEL 511FRN2000-08-18
3445321718296933K001829MINIMED PARADIGM INSULIN PUMP, MODEL 511FRN2000-08-18
1565991246631724K001828PARADIGM 1.5ML RESERVOIR, MODEL 326FRN2000-08-18
3445321246631724K001828PARADIGM 1.5ML RESERVOIR, MODEL 326FRN2000-08-18
1565991333085344
1565991581908920
1565991625244409
1565991637478646
1565991684260090
1565991863488921
1565991919979144
1565991948594558
3445321094758324
3445321333085344
3445321422805867
3445321530098908
3445321536544339
3445321581908920
3445321625244409
3445321637478646
3445321788672507
3445321863488921
3445321919979144
3445321963882653

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA152016-08-10
LZG112022-04-06
MDS82018-03-08
KZH82016-09-22
FRN82003-08-22
NDC62026-01-08
OZO42016-08-10
MRZ42007-10-17
QFG32026-03-12
QJI32026-02-03
OZP22016-09-28
PJT22015-05-19
FMF12016-07-26

PMA#

200 records. Showing 1-40. Next

PMN#

44 records. Showing 1-40. Next