PMA P140015S006
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S006
- Product code
- MDS
- Decision date
- 2016-03-24
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for a change in packaging for the replacement pump of the t:slim G4 insulin pump system with Dexcom G4 Platinum CGM.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S006
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2016-03-24
- Decision code
- APPR
- Date received
- 2015-12-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in packaging for the replacement pump of the t:slim G4 insulin pump system with Dexcom G4 Platinum CGM.