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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 Sensor (3)
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160007
Supplement NumberS004
Date Received05/18/2018
Decision Date08/16/2018
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02246582
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for a minor design change to the introducer needle component of the Guardian Sensor (3) for the Guardian Connect System along with the addition of an alternate needle supplier.
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