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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.
 
DeviceMedtronic MiniMed 630G Insulin Pump
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS015
Date Received05/08/2017
Decision Date06/06/2017
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Changes to update tester software that performs a series of tasks during final acceptance activities, after 630G and 670G insulin pumps have been fully assembled. The 630G insulin pump is part of the MiniMed 630G system and the 670G insulin pump is part of the MiniMed 670G system.
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