Premarket Approval (PMA)

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.

• Device: MINIMED 630G SYSTEM WITH SMARTGUARD(TM)
• Generic Name: Automated insulin dosing , threshold suspend
• Applicant: Medtronic Minimed; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P150001
• Date Received: 01/08/2015
• Decision Date: 08/10/2016
• Product Code: OZO
• Docket Number: 16M-2500
• Notice Date: 09/06/2016
• Advisory Committee: Clinical Chemistry
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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: S002 S003 S004 S011 S012 S013 S014 S015 S005 S006 S007 ; S008 S009 S001 S016 S017 S019 S020 S021 S022 S034 S035 S036 ; S037 S038 S039 S040 S041 S026 S027 S028 S030 S044 S045 S046 ; S077 S087 S088 S068 S069 S070 S071 S081 S082 S052 S083 S084 ; S086 S092 S105 S096 S097 S098 S107 S023 S024 S025 S047 S048 ; S049 S050 S051 S042 S043 S031 S032 S033 S063 S064 S072 S055 ; S056 S089 S073 S074 S075 S076 S065 S066 S053 S054 S058 S059 ; S061 S062 S078 S079 S080 S099 S101 S102 S090 S091 S093 S094 ; S104 S108 S109 S110