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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.
 
DeviceSimplera (TM) System
Generic NameSensor, glucose, invasive, non-adjunctive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160007
Supplement NumberS052
Date Received08/21/2024
Decision Date09/17/2024
Product Code PQF 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02246582
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  
addition of two new sterilization chambers for sterilization of Simplera sensors. The Simplera sensor is a component of the Simplera System
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