Tandem Diabetes Care Inc

FDA Filings

This page includes the latest FDA filings for Tandem Diabetes Care Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQTNDMDUNS 827900809
FDA Registration(s)
Registration Number3007981285
FEI Number3007981285
NameTANDEM DIABETES CARE, INC.
Owner & OperatorTandem Diabetes Care, Inc.
Contact Address11075 Roselle Street
San Diego CA 92121 US
Official Correspondent
  • Julia A Kensick
  • x-858-2556390-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address11075 Roselle Street
San Diego, CA 92121 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device



Registration Number3016540876
FEI Number3016540876
NameTANDEM DIABETES CARE, INC.
Owner & OperatorTandem Diabetes Care, Inc.
Contact Address11075 Roselle Street
San Diego CA 92121 US
Official Correspondent
  • Julia A Kensick
  • x-858-2556390-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6495 Marindustry Place
San Diego, CA 92121 US
Establishment TypeRepack or Relabel Medical Device



Registration Number3013756811
FEI Number3013756811
NameTandem Diabetes Care, INC.
Owner & OperatorTandem Diabetes Care, Inc.
Contact Address11075 Roselle Street
San Diego CA 92121 US
Official Correspondent
  • Julia A Kensick
  • x-858-2556390-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10151 Barnes Canyon Road 10151 Barnes Canyon Road
San Diego, CA 92121 US
Establishment Type
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Tandem Diabetes Care, Inc.
Control-IQ Technology2020-06-16
Tandem Diabetes Care, Inc.
T:slim X2 Insulin Pump With Interoperable Technology2020-06-04
Tandem Diabetes Care, Inc.
Basal-IQ Technology2020-02-28
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ 2020-02-12
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ 2020-02-12
TANDEM DIABETES CARE, INC.
t:connect Mobile Application (iOS) 2020-01-22
TANDEM DIABETES CARE, INC.
t:connect Mobile Application (Android) 2020-01-22
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Control-IQ 2019-12-31
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Control-IQ 2019-12-31
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Control-IQ 2019-12-31
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2019-12-19
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System2019-12-19
Tandem Diabetes Care, Inc.
Control-IQ Technology2019-12-13
TANDEM DIABETES CARE, INC.
t:slim Cartridge, t:lock, 10 Pack 2019-11-14
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System2019-03-01
Tandem Diabetes Care, Inc.
T:slim X2 Insulin Pump With Interoperable Technology2019-02-14
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2018-11-29
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2018-11-29
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2018-11-29
TANDEM DIABETES CARE, INC.
t:slim X2 5.0 Insulin Pump 2018-11-15
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2018-10-26
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM2018-10-26
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2018-10-11
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM2018-10-11
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ 2018-09-03
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ 2018-09-03
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ 2018-09-03
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ 2018-09-03
Tandem Diabetes Care, INC.
t:slim X22018-07-27
Tandem Diabetes Care, INC.
t:slim X2 with Basal-IQ2018-07-27
Tandem Diabetes Care, INC.
t:slim X2 Insulin Pump2018-07-27
Tandem Diabetes Care, INC.
t:slim X2 Insulin Pump with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X22018-07-27
TANDEM DIABETES CARE, INC.
t:slim X22018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ2018-07-27
Tandem Diabetes Care, INC.
t:slim X22018-07-27
Tandem Diabetes Care, INC.
t:slim X2 with Basal-IQ2018-07-27
Tandem Diabetes Care, INC.
t:slim X2 Insulin Pump2018-07-27
Tandem Diabetes Care, INC.
t:slim X2 Insulin Pump with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X22018-07-27
TANDEM DIABETES CARE, INC.
t:slim X22018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump with Basal-IQ2018-07-27
TANDEM DIABETES CARE, INC.
t:slim X2 5.0 Insulin Pump 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim X2 5.0 Insulin Pump 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim X2 5.0 Insulin Pump 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim X2 5.0 Insulin Pump 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim X2 Cartridge, t:lock, 2 Pack 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim X2 Cartridge, t:lock, 10 Pack 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump, Reconditioned 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump, Reconditioned Replacement 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, Replacement 0078292018-07-06
TANDEM DIABETES CARE, INC.
t:slim G4 Cartridge 2 Pack 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim G4 Cartridge 10 Pack 2018-07-06
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM 2018-07-06
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Basal-IQ Technology2018-06-21
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System2018-05-02
Tandem Diabetes Care, Inc.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM2018-04-17
TANDEM DIABETES CARE, INC.
t:slim Cartridge, t:lock, 10 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Cartridge, t:lock, 2 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Cartridge, t:lock, 10 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Cartridge, t:lock, 2 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim X2 Pump, Replacement, Refurb. 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Cartridge 2 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Cartridge 2 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Insulin Pump, Reconditioned 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Insulin Pump, Demonstration 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Insulin Pump, Replacement 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Insulin Pump, Replacement, Refurbished 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Insulin Pump, Replacement 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Insulin Pump, Reconditioned Replacement 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Cartridge 10 Pack 2018-03-29
TANDEM DIABETES CARE, INC.
t:flex Insulin Pump 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Insulin Pump, Reconditioned 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Insulin Pump 2018-03-29
TANDEM DIABETES CARE, INC.
t:slim Cartridge 10 Pack 2018-03-29
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM2018-02-14
Tandem Diabetes Care, Inc.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2017-12-21
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM2017-08-25
Tandem Diabetes Care, Inc.
G4 Insulin Pump with Dexcom G4 Platinum CGM System2017-06-15
Tandem Diabetes Care, INC.
t:slim X22017-04-26
Tandem Diabetes Care, INC.
Tandem Device Updater2017-04-26
TANDEM DIABETES CARE, INC.
t:slim X22017-04-26
TANDEM DIABETES CARE, INC.
Tandem Device Updater2017-04-26
Tandem Diabetes Care, INC.
t:slim X22017-04-26
Tandem Diabetes Care, INC.
Tandem Device Updater2017-04-26
TANDEM DIABETES CARE, INC.
t:slim X22017-04-26
TANDEM DIABETES CARE, INC.
Tandem Device Updater2017-04-26
Tandem Diabetes Care, INC.
t:slim X22017-04-26
TANDEM DIABETES CARE, INC.
t:slim X22017-04-26
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2017-03-20
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2017-03-06
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2017-02-08
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2017-01-18
Tandem Diabetes Care, Inc.
T:slim Insulin Delivery System, T:flex Insulin Delivery System, Tandem Device Updater2016-10-25
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-10-04
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM2016-10-04
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-09-23
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-09-08
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-09-01
Tandem Diabetes Care, Inc.
T:slim Insulin Delivery System2016-07-25
Tandem Diabetes Care, Inc.
T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-07-20
Tandem Diabetes Care, Inc.
T:slim Insulin Delivery System, T:flex Insulin Delivery System, Tandem Device Updater2016-07-13
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-07-08
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-03-24
Tandem Diabetes Care, INC.
t:slim Insulin Delivery System2016-03-02
Tandem Diabetes Care, INC.
t:flex Insulin Delivery System2016-03-02
Tandem Diabetes Care, INC.
Tandem t:slim Insulin Delivery System2016-03-02
TANDEM DIABETES CARE, INC.
t:slim Insulin Delivery System2016-03-02
TANDEM DIABETES CARE, INC.
t:flex Insulin Delivery System2016-03-02
TANDEM DIABETES CARE, INC.
Tandem t:slim Insulin Delivery System2016-03-02
Tandem Diabetes Care, INC.
t:slim Insulin Delivery System2016-03-02
TANDEM DIABETES CARE, INC.
t:slim Insulin Delivery System2016-03-02
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-01-28
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM2016-01-22
Tandem Diabetes Care, Inc.
TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM2015-10-15
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM2015-10-08
Tandem Diabetes Care, Inc.
TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.2015-10-08
Tandem Diabetes Care, Inc.
T SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM2015-10-08
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2015-10-08
Tandem Diabetes Care, INC.
t:slim G4 System2015-09-09
Tandem Diabetes Care, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2015-09-09
TANDEM DIABETES CARE, INC.
t:slim G4 System2015-09-09
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2015-09-09
Tandem Diabetes Care, INC.
t:slim G4 System2015-09-09
Tandem Diabetes Care, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2015-09-09
TANDEM DIABETES CARE, INC.
t:slim G4 System2015-09-09
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2015-09-09
Tandem Diabetes Care, INC.
t:slim G4 System2015-09-09
Tandem Diabetes Care, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2015-09-09
TANDEM DIABETES CARE, INC.
t:slim G4 System2015-09-09
TANDEM DIABETES CARE, INC.
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM2015-09-09
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2015-09-08
Tandem Diabetes Care, Inc.
T:flex Insulin Delivery System2015-01-09
TANDEM DIABETES CARE, INC.
T:SLIM INSULIN DELIVERY SYSTEM2014-10-31
Tandem Diabetes Care, INC.
t:slim insulin delivery system2014-05-29
TANDEM DIABETES CARE, INC.
t:slim insulin delivery system2014-05-29
TANDEM DIABETES CARE, INC.
T:SLIM INSULIN DELIVERY SYSTEM2014-03-24
Tandem Diabetes Care, INC.
t:slim X2 Insulin Pump2013-03-19
Tandem Diabetes Care, INC.
Tandem Diabetes Updater2013-03-19
TANDEM DIABETES CARE, INC.
t:slim X2 Insulin Pump2013-03-19
TANDEM DIABETES CARE, INC.
Tandem Diabetes Updater2013-03-19
TANDEM DIABETES CARE, INC.
T:CONNECT DATA MANAGEMENT SYSTEM2013-02-22
Tandem Diabetes Care, INC.
t:slim pump insulin delivery system2012-01-16
Tandem Diabetes Care, INC.
t:slim X22012-01-16
TANDEM DIABETES CARE, INC.
t:slim pump insulin delivery system2012-01-16
TANDEM DIABETES CARE, INC.
t:slim pump insulin delivery system2012-01-16
TANDEM DIABETES CARE, INC.
t:slim X22012-01-16
TANDEM DIABETES CARE, INC.
t:slim X22012-01-16
TANDEM DIABETES CARE, INC.
T:SLIM (TM) INSULIN DELIVERY SYSTEM2011-11-09

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