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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.
 
DeviceG4 Insulin Pump with Dexcom G4 Platinum 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 NumberS022
Date Received05/16/2017
Decision Date06/15/2017
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  
Modification to add a QC Manufacturing Aid to complement Quality Control acceptance review during the manufacturing of the t:slim G4 insulin pump, intended to be used with Dexcom G4 Continuous Glucose Monitoring (CGM) sensor and transmitter.
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