PMA P180008S006

Device: t:slim X2 Insulin Pump with Basal-IQ Technology
Applicant: Tandem Diabetes Care, Inc.
PMA number: P180008
Supplement: S006
Product code: OZO
Decision date: 2018-10-26
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
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 Basal-IQ Technology
Applicant: Tandem Diabetes Care, Inc.
PMA number: P180008
Supplement: S006
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
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.