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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 DexcomG5 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 NumberS025
Date Received02/01/2018
Decision Date05/02/2018
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 a design change to the insulin cartridge.
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