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U.S. Department of Health and Human Services

Devices@FDA
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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 St.
San Diego, CA 92121
PMA NumberP140015
Supplement NumberS029
Date Received11/20/2019
Decision Date12/19/2019
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.
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