MINIMED 530G SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Premarket Approval P120010 S083

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

Manufacturing facility move by medtronic’s enlite sensor substrate supplier. The enlite sensor is a component of the minimed 530g system and the paradigm real-time revel system with enlite sensor. The sensor substrate supplier, metrigraphics, llc, currently manufactures the enlite sensor substrate in wilmington, massachusetts and will start manufacturing at the new facility in lowell, massachusetts. The firm states that the current sensor substrate manufacturing facility will close at the end of lease.

DeviceMINIMED 530G SYSTEM
Classification NameAutomated Insulin Dosing , Threshold Suspend
Generic NameAutomated Insulin Dosing , Threshold Suspend
ApplicantMEDTRONIC Inc.
Date Received2016-02-23
Decision Date2016-03-23
PMAP120010
SupplementS083
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
S142 2022-11-04 30-day Notice
S141 2022-04-01 30-day Notice
S140 2021-11-17 Special (immediate Track)
S139 2021-01-27 Special (immediate Track)
S138 2020-11-03 30-day Notice
S137 2019-11-29 30-day Notice
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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