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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceGLUCOSE SENSOR ENLITE
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMEDTRONIC Inc.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP120010
Supplement NumberS019
Date Received03/21/2014
Decision Date06/18/2014
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) OF THE MINIMED 530G SYSTEM. SPECIFICALLY, THE SUPPLEMENT REQUESTED DESIGN MODIFICATIONS TO THE NEEDLE HUB AND NEEDLE CARRIER COMPONENTS OF THE ENLITE SENSOR TO FIT THE AUTOMATION MACHINE THAT WILL BE USED FOR THE SENSOR ASSEMBLY. ADDITIONALLY, THE NEW MANUFACTURING PROCESS WILL TAKE PLACE IN THE JUNCOS, PUERTO RICO MANUFACTURING SITE.
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