PMA P140015S012
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S012
- Product code
- OYC
- Decision date
- 2016-10-04
- 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 design and manufacturing changes to implement an alternative Screen On/Quick Bolus button on the t:slim G4 Insulin Pump. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM System.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S012
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-10-04
- Decision code
- APPR
- Date received
- 2016-07-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and manufacturing changes to implement an alternative Screen On/Quick Bolus button on the t:slim G4 Insulin Pump. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM System.