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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) System
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160007
Supplement NumberS005
Date Received05/31/2018
Decision Date06/26/2018
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  
Manufacturing changes for the Guardian Sensor (3): 1) adding a new ISO Class 8 Cleanroom for the manufacturing of Enlite Sensors and Guardian Sensors (3); 2) adding a new press, two new molds and a new quality control measurement system at the contract manufacturer; 3) adding an alternate injection molding machine and mold to produce the needle hub body component; 4) adding an alternative mask aligner; 5) adding a new electroplating machine; 6) adding a new sterilization site for the Enlite Sensor and the Guardian Sensor (3); 7) introducing an alternative press and mold to manufacture the sensor cap components of the Guardian Sensor (3) and implementing a new configuration number for parts manufactured. The Guardian Sensor (3) is a component of the Guardian Connect System
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