PMA P140015S023
- Device
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S023
- Product code
- OYC
- Decision date
- 2018-02-14
- 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
- Additional laser welding equipment and leak rate testing parameters for manufacturer of the t:slim insulin cartridge. The t:slim insulin cartridge is a component of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM.
Current openFDA PMA Record#
- Device
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S023
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2018-02-14
- Decision code
- OK30
- Date received
- 2018-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional laser welding equipment and leak rate testing parameters for manufacturer of the t:slim insulin cartridge. The t:slim insulin cartridge is a component of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM.