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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 G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
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 NumberS010
Date Received06/23/2016
Decision Date07/20/2016
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  
Automate the software loading process performed during manufacture of the t:slim G4 Insulin Pump at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.
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