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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 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.
Devicet:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
Generic Namepump, infusion, insulin, to be used with invasive glucose sensor
ApplicantTandem Diabetes Care, Inc.
11045 roselle street
san diego, CA 92121
PMA NumberP140015
Supplement NumberS028
Date Received01/16/2019
Decision Date03/01/2019
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.