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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.
 
DeviceENLITE SENSOR
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMEDTRONIC Inc.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP120010
Supplement NumberS063
Date Received02/26/2015
Decision Date03/23/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATION TO THE LASER CUTTING PARAMETERS FOR THE POTOMAC LASERSYSTEM USED DURING THE ENLITE SENSOR MANUFACTURING PROCESS IN ORDER TO QUALIFY IT FOR USE WITH THE 48-UP SENSOR CONFIGURATION. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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