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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.
 
DeviceENLITE SENSOR
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS040
Date Received10/30/2014
Decision Date05/13/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
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 A CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION.
Post-Approval StudyShow Report Schedule and Study Progress
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