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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.
 
DeviceMINIMED 630G pump
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS003
Date Received10/24/2016
Decision Date01/06/2017
Product Code OZO 
Advisory Committee Clinical Chemistry
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 a design modification to the vibrator motor assembly in the MiniMed 630G Insulin Pump; a reduced sampling plan for acceptance testing by the vibrator motor assembly supplier; and for elimination of incoming acceptance testing of the vibrator motor assembly. The MiniMed 630G Insulin Pump is a component of the MiniMed 630G System with Smartguard.
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