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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 NumberS035
Date Received05/18/2020
Decision Date01/14/2021
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02246582
Supplement Type135 Review Track For 30-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  
Approval for manufacturing changes related to sterilization process for Guardian Sensor (3). The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.
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