t:slim X2 Insulin Pump with Basal-IQ Technology

FDA Premarket Approval P180008 S007

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 of a 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

• Device: t:slim X2 Insulin Pump with Basal-IQ Technology
• Generic Name: Automated Insulin Dosing , Threshold Suspend
• Applicant: Tandem Diabetes Care, Inc.
• Date Received: 2019-11-20
• Decision Date: 2019-12-19
• PMA: P180008
• Supplement: S007
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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