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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 G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile 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
Supplement NumberS024
Date Received01/17/2018
Decision Date04/17/2018
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for minor design changes to the pump housing and patient line port of the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a part of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System.
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