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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 NumberS001
Date Received11/06/2013
Decision Date10/02/2015
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 ADDING DUPLICATE EXISTING MANUFACTURING STEPS TO THE PREPARATION OF BULK GLUCOSE OXIDASE (GOX) PERFORMED BY THE SUPPLIER FOR USE IN THE SPONSOR¿S ENLITE SENSOR (MODEL: MMT-7008) AND SOF-SENSOR (MODELS: MMT-7002 AND MMT-7003) DEVICES. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REALTIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO RECORDER AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS.
Post-Approval StudyShow Report Schedule and Study Progress
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