PMA P180008

Device: t:slim X2 Insulin Pump with Basal-IQ Technology
Applicant: Tandem Diabetes Care, Inc.
PMA number: P180008
Supplement: S007
Product code: OZO
Decision date: 2019-12-19
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.

Current openFDA PMA Record#

Device: t:slim X2 Insulin Pump with Basal-IQ Technology
Applicant: Tandem Diabetes Care, Inc.
PMA number: P180008
Supplement: S007
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2019-12-19
Decision code: OK30
Date received: 2019-11-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.