PMA P180008S002
- Device
- t:slim X2 Insulin Pump with Basal-IQ Technology
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P180008
- Supplement
- S002
- Product code
- OZO
- Decision date
- 2018-11-29
- Classification
- Automated Insulin Dosing , Threshold Suspend
- Generic name
- Automated insulin dosing , threshold suspend
- Approval order statement
- Approval to modify the menu settings software and add a secondary display.
Current openFDA PMA Record#
- Device
- t:slim X2 Insulin Pump with Basal-IQ Technology
- Applicant
- Tandem Diabetes Care, Inc.
- PMA number
- P180008
- Supplement
- S002
- Product code
- OZO
- Generic name
- Automated insulin dosing , threshold suspend
- Decision date
- 2018-11-29
- Decision code
- APPR
- Date received
- 2018-08-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the menu settings software and add a secondary display.