Medtronic MiniMed 530G System

Automated Insulin Dosing , Threshold Suspend

FDA Premarket Approval P120010 S135

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.

Pre-market Approval Supplement Details

Packaging, labeling, and final release activities of the one-press serter conducted at medtronic, inc. To be moved to contract manufacturer facility. The one-press serter is a component of the 530g system, the 630g system, the 670g system, and the guardian connect system.

DeviceMedtronic MiniMed 530G System
Classification NameAutomated Insulin Dosing , Threshold Suspend
Generic NameAutomated Insulin Dosing , Threshold Suspend
ApplicantMEDTRONIC Inc.
Date Received2019-10-11
Decision Date2019-11-04
PMAP120010
SupplementS135
Product CodeOZO
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 18000 Devonshire Street northridge, CA 91325-1219

Supplemental Filings

Supplement NumberDateSupplement Type
P120010Original Filing
S136 2019-10-17 30-day Notice
S135 2019-10-11 30-day Notice
S134
S133 2019-08-21 30-day Notice
S132 2019-07-15 30-day Notice
S131 2019-06-19 30-day Notice
S130
S129 2019-02-11 30-day Notice
S128 2019-02-01 30-day Notice
S127
S126 2018-11-07 30-day Notice
S125 2018-11-07 30-day Notice
S124 2018-11-07 30-day Notice
S123 2018-11-02 30-day Notice
S122 2018-10-15 30-day Notice
S121 2018-10-01 30-day Notice
S120 2018-07-16 30-day Notice
S119 2018-07-09 30-day Notice
S118 2018-06-19 30-day Notice
S117 2018-06-07 Special (immediate Track)
S116 2018-04-30 30-day Notice
S115 2018-03-26 30-day Notice
S114 2018-03-12 30-day Notice
S113 2018-02-09 Real-time Process
S112 2018-02-07 30-day Notice
S111 2018-01-29 30-day Notice
S110 2018-01-29 30-day Notice
S109 2017-12-22 30-day Notice
S108 2017-12-20 Real-time Process
S107 2017-11-24 30-day Notice
S106 2017-10-30 30-day Notice
S105 2017-07-17 30-day Notice
S104 2017-05-30 30-day Notice
S103 2017-04-10 30-day Notice
S102 2017-03-31 30-day Notice
S101 2017-02-03 Normal 180 Day Track No User Fee
S100 2016-12-23 Real-time Process
S099 2016-11-28 30-day Notice
S098 2016-11-28 30-day Notice
S097 2016-11-02 30-day Notice
S096
S095 2016-09-19 30-day Notice
S094
S093 2016-07-26 30-day Notice
S092 2016-07-21 30-day Notice
S091 2016-06-15 135 Review Track For 30-day Notice
S090
S089 2016-04-27 135 Review Track For 30-day Notice
S088 2016-03-28 30-day Notice
S087 2016-03-25 30-day Notice
S086 2016-03-25 30-day Notice
S085 2016-03-09 30-day Notice
S084 2016-03-07 30-day Notice
S083 2016-02-23 30-day Notice
S082 2015-12-28 30-day Notice
S081 2015-12-15 30-day Notice
S080 2015-11-27 30-day Notice
S079 2015-11-09 30-day Notice
S078 2015-11-09 30-day Notice
S077 2015-11-09 30-day Notice
S076 2015-11-03 135 Review Track For 30-day Notice
S075 2015-11-03 30-day Notice
S074 2015-11-02 Real-time Process
S073 2015-10-19 30-day Notice
S072 2015-08-10 135 Review Track For 30-day Notice
S071 2015-07-20 Normal 180 Day Track No User Fee
S070 2015-06-09 Normal 180 Day Track
S069 2015-05-29 30-day Notice
S068 2015-05-01 135 Review Track For 30-day Notice
S067 2015-04-29 Real-time Process
S066 2015-04-20 30-day Notice
S065 2015-03-18 30-day Notice
S064 2015-03-10 135 Review Track For 30-day Notice
S063 2015-02-26 30-day Notice
S062 2015-02-18 Real-time Process
S061 2015-02-06 Real-time Process
S060 2015-01-30 30-day Notice
S059 2015-01-28 30-day Notice
S058 2015-01-26 135 Review Track For 30-day Notice
S057 2015-01-26 30-day Notice
S056 2015-01-06 Real-time Process
S055 2014-12-31 30-day Notice
S054 2014-12-30 Real-time Process
S053 2014-12-30 30-day Notice
S052 2015-02-17 Normal 180 Day Track
S051 2014-12-15 30-day Notice
S050 2014-12-10 30-day Notice
S049 2014-12-04 30-day Notice
S048 2014-12-02 30-day Notice
S047 2014-11-26 30-day Notice
S046 2014-12-10 Panel Track
S045 2014-11-04 30-day Notice
S044
S043 2014-11-03 30-day Notice
S042 2014-10-31 Real-time Process
S041 2014-10-30 Real-time Process
S040 2014-10-30 135 Review Track For 30-day Notice
S039 2014-10-27 30-day Notice
S038 2014-10-22 30-day Notice
S037 2014-10-20 30-day Notice
S036 2014-09-22 Real-time Process
S035 2014-09-05 30-day Notice
S034 2014-09-04 30-day Notice
S033 2014-08-11 135 Review Track For 30-day Notice
S032 2014-08-01 Normal 180 Day Track No User Fee
S031 2014-07-29 30-day Notice
S030 2014-07-07 Real-time Process
S029 2014-07-11 Normal 180 Day Track
S028 2014-06-24 30-day Notice
S027 2014-06-23 30-day Notice
S026 2014-06-23 Real-time Process
S025 2014-06-03 30-day Notice
S024 2014-06-02 Real-time Process
S023 2014-04-29 135 Review Track For 30-day Notice
S022 2014-04-14 30-day Notice
S021 2014-04-11 Real-time Process
S020 2014-04-11 30-day Notice
S019 2014-03-21 Real-time Process
S018
S017 2014-03-10 30-day Notice
S016 2014-03-06 Real-time Process
S015 2014-03-04 30-day Notice
S014 2014-03-04 30-day Notice
S013 2014-02-24 30-day Notice
S012 2014-02-20 30-day Notice
S011 2014-02-18 30-day Notice
S010 2014-02-06 30-day Notice
S009 2014-01-28 30-day Notice
S008 2013-12-23 Real-time Process
S007
S006 2013-11-08 30-day Notice
S005 2013-11-08 135 Review Track For 30-day Notice
S004 2013-11-08 135 Review Track For 30-day Notice
S003 2013-11-07 135 Review Track For 30-day Notice
S002 2013-11-07 Special (immediate Track)
S001 2013-11-06 135 Review Track For 30-day Notice

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