PMA P180008S005

Device: t:slim X2 Insulin Pump with Basal-IQ Technology
Applicant: Tandem Diabetes Care, Inc.
PMA number: P180008
Supplement: S005
Product code: OZO
Decision date: 2018-10-11
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Removal of plasma treatment on the patient line, modification to the final packing verification process, and the addition of additional testing/acceptance criteria for the pumps. The Tandem cartridges and pumps are part 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: S005
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2018-10-11
Decision code: OK30
Date received: 2018-09-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Removal of plasma treatment on the patient line, modification to the final packing verification process, and the addition of additional testing/acceptance criteria for the pumps. The Tandem cartridges and pumps are part of the Tandem t:slim X2 Insulin Pump system.