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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.
 
DeviceTSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Generic NameSensor, glucose, invasive
ApplicantTandem Diabetes Care, Inc.
11045 Roselle St.
San Diego, CA 92121
PMA NumberP140015
Supplement NumberS005
Date Received09/18/2015
Decision Date10/15/2015
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  
REMOVAL OF A NON-DESTRUCTIVE TEST AND A MOVE OF AN EXISTING DESTRUCTIVE TEST TO AN EARLIER POINT IN THE MANUFACTURING PROCESS OF THE T:SLIM INSULIN CARTRIDGE. THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.
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