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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
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS030
Date Received11/24/2017
Decision Date12/21/2017
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  
Addition of a new sterilization site for the Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of MiniMed 530G System, MiniMed Paradigm Real-Time Revel System, and MiniMed iPro2 CGM System with Enlite Sensor. The Guardian Sensor (3) is a component of MiniMed 630G System with SmartGuard and the MiniMed 670G System.
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