PMA P140015S028
- Device
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S028
- Product code
- OYC
- Decision date
- 2019-03-01
- 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
- Introduce alternate suppliers for PCB and PCBA parts for the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a component of the Dexcom G5 Mobile CGM System.
Current openFDA PMA Record#
- Device
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S028
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2019-03-01
- Decision code
- OK30
- Date received
- 2019-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce alternate suppliers for PCB and PCBA parts for the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a component of the Dexcom G5 Mobile CGM System.