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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 G4 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 NumberS019
Date Received01/17/2017
Decision Date02/08/2017
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  
Combine lot release testing and in-process monitoring testing for the t:slim insulin cartridge component and to remove several redundant test procedures. The t:slim insulin cartridge is a component of the Tandem t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
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