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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 NumberS030
Date Received07/07/2014
Decision Date02/04/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES TO THE SENSOR BASE WHICH INCLUDED; THE ADDITION OF ANTI-ROTATION PINS AND SNAP ARMS, MODIFICATION OF THE O-RING GLAND; WIDTH, POSITION, AND DIAMETER, AN INCREASE TO THE BORE SIZE AND ADDITION OF A BORE TAPER, A SENSOR THROUGH-HOLE SIZE INCREASE, AND CONNECTOR PAD SURFACE HEIGHT INCREASE, ON THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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