PMA P140015S024
- Device
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S024
- Product code
- OYC
- Decision date
- 2018-04-17
- Classification
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Approval order statement
- Approval for minor design changes to the pump housing and patient line port of the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a part of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System.
Current openFDA PMA Record#
- Device
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S024
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2018-04-17
- Decision code
- APPR
- Date received
- 2018-01-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the pump housing and patient line port of the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a part of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System.