T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM

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

FDA Premarket Approval P140015 S011

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 for modifications to the fuel gauge register to change the how the t:slim g4 system reads the battery level.

DeviceT:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Classification NamePump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Generic NamePump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
ApplicantTandem Diabetes Care, Inc.
Date Received2016-07-11
Decision Date2016-10-04
PMAP140015
SupplementS011
Product CodeOYC
Advisory CommitteeClinical Chemistry
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Tandem Diabetes Care, Inc. 11045 Roselle Street san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P140015Original 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 IDPMASupp
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

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