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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.
 
DeviceMiniMed 630G Insulin Pump
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP150001
Supplement NumberS028
Date Received10/30/2017
Decision Date12/20/2017
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1) minor design changes to the electronics board stack used in the 630G insulin pump; 2) a new supplier for the electronics board stack; 3) an updated pump software version; and 4) an extension to the 630G insulin pump shelf life from 185 days to 1095 days.
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