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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceT:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Generic NamePump, infusion, insulin, to be used with invasive glucose sensor
ApplicantTandem Diabetes Care, Inc.
11045 Roselle Street
San Diego, CA 92121
PMA NumberP140015
Date Received07/17/2014
Decision Date09/08/2015
Product Codes MDS OYC 
Docket Number 15M-3376
Notice Date 10/15/2015
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (¿T:SLIM G4 SYSTEM¿). THIS DEVICE CONSISTS OF THE T:SLIM G4 INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE T:SLIM G4 INSULIN PUMP IS INTENDED FOR THE SUBCUTANEOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. THE T:SLIM G4 INSULIN PUMP CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY AND AS PART OF THE T:SLIM G4 SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER. THE T:SLIM G4 SYSTEM ALSO INCLUDES CONTINUOUS GLUCOSE MONITORING (CGM) INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS WITH DIABETES FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE T:SLIM G4 SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE T:SLIM G4 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME. THE T:SLIM G4 SYSTEM IS INDICATED FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND GREATER. THE T:SLIM G4 SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 
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