PMA P140015S027
- Device
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S027
- Product code
- OYC
- Decision date
- 2018-10-26
- 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
- Change the procedure for wake button replacement during PCBA refurbishment by discontinuing replacement of the wake button if it meets specific criteria and by transferring various reprogramming steps in-house. The wake button switch assemblies are components of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and the t:slim Insulin Pump with Basal-IQ Technology.
Current openFDA PMA Record#
- Device
- t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P140015
- Supplement
- S027
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2018-10-26
- Decision code
- OK30
- Date received
- 2018-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the procedure for wake button replacement during PCBA refurbishment by discontinuing replacement of the wake button if it meets specific criteria and by transferring various reprogramming steps in-house. The wake button switch assemblies are components of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and the t:slim Insulin Pump with Basal-IQ Technology.