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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.
 
DeviceGuardian Connect System Simplera System
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160007
Supplement NumberS056
Date Received09/19/2025
Decision Date10/16/2025
Product Code MDS 
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 a new supplier for a critical component of the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. The Guardian 4 Sensor is a component of the MiniMed 780G System
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