Tandem Diabetes Care, Inc

FDA Filings

This page includes the latest FDA filings for Tandem Diabetes Care, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
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 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 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 Dexcom G5 Mobile CGM2018-10-11
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 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 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 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 G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM2016-10-04
Tandem Diabetes Care, Inc.
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-10-04
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 G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM2016-07-20
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 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

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Tandem Diabetes Care, Inc.
T:slim X2 Insulin Pump With Interoperable Technology2019-02-14

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
t:slim Cartridge, t:lock, 10 Pack
TANDEM DIABETES CARE, INC.2019-11-14
t:slim X2 5.0 Insulin Pump
TANDEM DIABETES CARE, INC.2018-11-15
t:slim X2 Insulin Pump with Basal-IQ
TANDEM DIABETES CARE, INC.2018-09-03
t:slim X2 Insulin Pump with Basal-IQ
TANDEM DIABETES CARE, INC.2018-09-03
t:slim X2 Insulin Pump with Basal-IQ
TANDEM DIABETES CARE, INC.2018-09-03
t:slim X2 Insulin Pump with Basal-IQ
TANDEM DIABETES CARE, INC.2018-09-03
t:slim G4 Insulin Pump, Reconditioned
TANDEM DIABETES CARE, INC.2018-07-06
t:slim G4 Insulin Pump, Reconditioned Replacement
TANDEM DIABETES CARE, INC.2018-07-06
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
TANDEM DIABETES CARE, INC.2018-07-06
t:slim G4 Cartridge 2 Pack
TANDEM DIABETES CARE, INC.2018-07-06
t:slim G4 Cartridge 10 Pack
TANDEM DIABETES CARE, INC.2018-07-06
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 5.0 Insulin Pump
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 5.0 Insulin Pump
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 5.0 Insulin Pump
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 5.0 Insulin Pump
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 Cartridge, t:lock, 2 Pack
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 Cartridge, t:lock, 10 Pack
TANDEM DIABETES CARE, INC.2018-07-06
t:slim X2 Insulin Pump
TANDEM DIABETES CARE, INC.2018-03-29
t:slim X2 Insulin Pump
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Cartridge 2 Pack
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Cartridge 2 Pack
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Insulin Pump, Reconditioned
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Insulin Pump, Demonstration
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Insulin Pump, Replacement
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Insulin Pump, Replacement, Refurbished
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Insulin Pump, Replacement
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Insulin Pump, Reconditioned Replacement
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Cartridge 10 Pack
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Insulin Pump
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Insulin Pump, Reconditioned
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Insulin Pump
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Cartridge 10 Pack
TANDEM DIABETES CARE, INC.2018-03-29
t:slim Cartridge, t:lock, 10 Pack
TANDEM DIABETES CARE, INC.2018-03-29
t:flex Cartridge, t:lock, 2 Pack
TANDEM DIABETES CARE, INC.2018-03-29

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.