PMA P140015S025
- Device
- t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S025
- Product code
- OYC
- Decision date
- 2018-05-02
- 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 insulin cartridge.
Current openFDA PMA Record#
- Device
- t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S025
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2018-05-02
- Decision code
- APPR
- Date received
- 2018-02-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the insulin cartridge.