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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMINIMED 630G SYSTEM WITH SMARTGUARD(TM)
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP150001
Date Received01/08/2015
Decision Date08/10/2016
Product Code OZO 
Docket Number 16M-2500
Notice Date 09/06/2016
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the MiniMed 630G System with SmartGuard.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S011 S012 S013 S014 S015 S016 S017 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 
S058 S059 S061 S062 S063 S064 S065 S066 S068 
S069 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S082 S083 S086 
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