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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 G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Generic NameSensor, glucose, invasive
ApplicantTandem Diabetes Care, Inc.
11045 Roselle St.
San Diego, CA 92121
PMA NumberP140015
Supplement NumberS007
Date Received12/30/2015
Decision Date01/28/2016
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
Approval Order Statement  
CHANGES TO THE PACKAGING VERIFICATION PROCESSES TO REPLACE 100% VISUAL INSPECTION WITH 100% PACKAGE CONTENTS VERIFICATION USING VALIDATED CHECKWEIGHT SCALE, AND CHANGES TO THE LABELING VERIFICATION PROCESS TO REPLACE 100% VISUAL VERIFICATION WITH ONCE-DAILY VISUAL INSPECTION OF A RETAINED LABEL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.
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