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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 System with SmartGuard
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS075
Date Received09/30/2019
Decision Date10/30/2019
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  
Addition of a new curing process to increase production capacity of the MiniMed 630G Insulin Pump and the MiniMed670G Insulin Pump. The MiniMedi 630G Insulin pump is a component of the MiniMed 630G System with Smartguard. The MiniMed 670G Insulin Pump is a component of the MiniMed 670G System.
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