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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 NumberS082
Date Received12/28/2015
Decision Date01/27/2016
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  
THE APPROVAL OF A TRANSITION OF THE MANUFACTURING OF THE TYVEK LIDS USED FOR PACKAGING THE ENLITE SENSOR COMPONENT FROM THE SUPPLIER'S FACILITY IN PHILADELPHIA TO OSHKOSH, WISCONSIN. ADDITIONALLY, THE FACILITY TRANSITION INCLUDES NEW MANUFACTURING ASSETS INCLUDING COATER AND DIE CUT LID PRESS. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEMS.
Post-Approval StudyShow Report Schedule and Study Progress
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