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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 4 Sensor
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS119
Date Received06/20/2024
Decision Date07/17/2024
Product Code OZP 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02130284
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  
a new sterilization site for the sterilization of the Guardian Sensor (4) sensors that are manufactured at Medtronic Puerto Rico Operations Company. The Guardian Sensor (4) is a component of the Guardian Connect system and the MiniMed 670G, 770G, and 780G systems
Post-Approval StudyShow Report Schedule and Study Progress
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