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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 GLUCOSE SENSOR
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS024
Date Received06/02/2014
Decision Date02/19/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL CHANGES TO THE DESIGN AND MANUFACTURING OF THE NEEDLE FORTHE MEDTRONIC MINIMED 530G SYSTEM ENLITE GLUCOSE SENSOR (MMT-7008A, MMT- 7008B); THE SPECIFICALLY PROPOSED CHANGES WHICH INFLUENCE THE ENLITE NEEDLE TO INTRODUCE A BEVEL AT THE NEEDLE TIP AND INCREASE NEEDLE SHARPNESS.
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