t:slim X2 Insulin Pump with Basal-IQ Technology

Automated Insulin Dosing , Threshold Suspend

FDA Premarket Approval P180008 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to modify the menu settings software and add a secondary display.

• Device: t:slim X2 Insulin Pump with Basal-IQ Technology
• Classification Name: Automated Insulin Dosing , Threshold Suspend
• Generic Name: Automated Insulin Dosing , Threshold Suspend
• Applicant: Tandem Diabetes Care, Inc.
• Date Received: 2018-08-31
• Decision Date: 2018-11-29
• PMA: P180008
• Supplement: S002
• Product Code: OZO
• Advisory Committee: Clinical Chemistry
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Tandem Diabetes Care, Inc. 11075 Roselle Street san Diego, CA 92121

Supplemental Filings

Supplement Number	Date	Supplement Type
P180008		Original Filing
S007	2019-11-20	30-day Notice
S006	2018-09-27	30-day Notice
S005	2018-09-12	30-day Notice
S004
S003	2018-08-31	Real-time Process
S002	2018-08-31	Real-time Process
S001	2018-08-31	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00853052007325	P180008	000
00853052007301	P180008	000
00853052007288	P180008	000
00853052007264	P180008	000
00850006613380	P180008	000
00850006613373	P180008	000