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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 NumberS007
Date Received06/19/2018
Decision Date07/16/2018
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  
Relocating the molding process to a new manufacturing location and adding replacement presses and new molds for the needle hub assembly parts of the Enlite 3 Sensor and the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite 3 Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems.
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