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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameT:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Classification Namepump, infusion, insulin, to be used with invasive glucose sensor
ApplicantTANDEM DIABETES CARE, INC.
PMA NumberP140015
Supplement NumberS004
Date Received09/11/2015
Decision Date10/08/2015
Product Code
OYC[ Registered Establishments with OYC ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a second head-to-bag insulin cartridge subassembly test system. The insulin cartridge is a disposable component of the t:slim g4 insulin pump with dexcom g4 platinum cgm.
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