t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Premarket Approval P140015 S028

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

Introduce alternate suppliers for pcb and pcba parts for the t:slim x2 insulin pump. The t:slim x2 insulin pump is a component of the dexcom g5 mobile cgm system.

• Device: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
• Classification Name: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
• Generic Name: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
• Applicant: Tandem Diabetes Care, Inc.
• Date Received: 2019-01-16
• Decision Date: 2019-03-01
• PMA: P140015
• Supplement: S028
• Product Code: OYC
• 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. 11045 Roselle Street san Diego, CA 92121

Supplemental Filings

Supplement Number	Date	Supplement Type
P140015		Original Filing
S029	2019-11-20	30-day Notice
S028	2019-01-16	30-day Notice
S027	2018-09-27	30-day Notice
S026	2018-09-12	30-day Notice
S025	2018-02-01	Real-time Process
S024	2018-01-17	Real-time Process
S023	2018-01-16	30-day Notice
S022	2017-05-16	30-day Notice
S021	2017-04-03	Normal 180 Day Track No User Fee
S020	2017-03-01	Panel Track
S019	2017-01-17	30-day Notice
S018	2016-12-23	30-day Notice
S017	2016-12-21	Real-time Process
S016	2016-12-12	Real-time Process
S015	2016-08-23	30-day Notice
S014	2016-08-10	30-day Notice
S013	2016-08-03	30-day Notice
S012	2016-07-12	Real-time Process
S011	2016-07-11	Real-time Process
S010	2016-06-23	30-day Notice
S009	2016-06-09	30-day Notice
S008	2015-12-30	30-day Notice
S007	2015-12-30	30-day Notice
S006	2015-12-29	Real-time Process
S005	2015-09-18	30-day Notice
S004	2015-09-11	30-day Notice
S003	2015-09-11	30-day Notice
S002	2015-09-11	30-day Notice
S001	2015-09-11	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00853052007967	P140015	000
00852162004408	P140015	000
00852162004415	P140015	000
00852162004422	P140015	000
00852162004439	P140015	000
00852162004613	P140015	000
00852162004750	P140015	000
00853052007226	P140015	000
00853052007233	P140015	000
00853052007257	P140015	000
00853052007271	P140015	000
00853052007295	P140015	000
00853052007318	P140015	000
00853052007981	P140015	000