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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.
 
DeviceArtificial Pancreas Device System Threshold Suspend
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS102
Date Received03/31/2017
Decision Date04/27/2017
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
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 inspections and inspection equipment by contract manufacturer of introducer needle in the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor is a component of the MiniMed 530G System, the MiniMed 630G System With SmartGuard, the Paradigm Real-Time Revel System with Enlite Sensor, and iPro2 CGM System with Enlite Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G System.
Post-Approval StudyShow Report Schedule and Study Progress
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