PMA P140015S017
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S017
- Product code
- OYC
- Decision date
- 2017-03-20
- 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 a design change to the connector between the cartridge and the infusion set.
Current openFDA PMA Record#
- Device
- T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S017
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2017-03-20
- Decision code
- APPR
- Date received
- 2016-12-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the connector between the cartridge and the infusion set.