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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
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160007
Supplement NumberS013
Date Received02/01/2019
Decision Date03/13/2019
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  
Additional injection molding equipment at a contract manufacturer in order to increase production capacity for the Guardian Sensor (3) and Enlite Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems.
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