G5 Mobile Continuous Glucose Monitoring System

FDA Premarket Approval P120005 S087

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

Progress adequate

DeviceG5 Mobile Continuous Glucose Monitoring System
Generic NameSensor, Glucose, Invasive
ApplicantDEXCOM, INC.
Date Received2020-08-06
Decision Date2020-09-03
PMAP120005
SupplementS087
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address DEXCOM, INC. 6340 Sequence Dr san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P120005Original Filing
S087 2020-08-06 Normal 180 Day Track No User Fee
S086 2019-12-09 30-day Notice
S085
S084
S083 2019-06-27 Normal 180 Day Track No User Fee
S082 2019-06-11 Real-time Process
S081 2019-03-12 Real-time Process
S080 2019-01-22 Normal 180 Day Track No User Fee
S079 2018-11-05 30-day Notice
S078 2018-09-07 30-day Notice
S077 2018-08-08 Real-time Process
S076 2018-05-23 30-day Notice
S075 2018-05-18 30-day Notice
S074 2018-05-14 30-day Notice
S073 2018-04-04 Real-time Process
S072
S071 2018-02-27 30-day Notice
S070
S069 2017-12-11 30-day Notice
S068 2017-10-16 30-day Notice
S067 2017-10-10 Normal 180 Day Track No User Fee
S066 2017-08-17 30-day Notice
S065 2017-07-10 Real-time Process
S064 2017-06-29 Real-time Process
S063 2017-04-10 30-day Notice
S062 2017-04-04 30-day Notice
S061 2017-04-03 30-day Notice
S060 2017-03-01 135 Review Track For 30-day Notice
S059 2017-01-19 Normal 180 Day Track No User Fee
S058 2016-12-21 30-day Notice
S057 2016-10-20 Normal 180 Day Track
S056 2016-10-11 30-day Notice
S055 2016-09-14 Real-time Process
S054
S053 2016-07-28 Real-time Process
S052 2016-07-27 30-day Notice
S051 2016-07-15 30-day Notice
S050 2016-06-22 Normal 180 Day Track
S049 2016-06-21 Real-time Process
S048 2016-05-06 Real-time Process
S047 2016-04-26 Real-time Process
S046 2016-03-25 30-day Notice
S045
S044 2015-12-17 30-day Notice
S043 2015-12-15 30-day Notice
S042 2015-11-24 Normal 180 Day Track
S041 2015-09-25 Panel Track
S040 2015-09-25 135 Review Track For 30-day Notice
S039 2015-09-23 30-day Notice
S038 2015-08-10 Real-time Process
S037 2015-07-16 Real-time Process
S036 2015-05-14 Real-time Process
S035 2015-05-08 30-day Notice
S034 2015-03-17 30-day Notice
S033 2015-02-25 Normal 180 Day Track
S032 2014-12-23 30-day Notice
S031 2014-11-26 Panel Track
S030 2014-11-14 30-day Notice
S029 2014-10-27 30-day Notice
S028 2014-09-12 Normal 180 Day Track
S027 2014-07-24 30-day Notice
S026 2014-07-21 Real-time Process
S025 2014-06-26 30-day Notice
S024 2014-06-18 30-day Notice
S023 2014-06-16 30-day Notice
S022 2014-06-13 30-day Notice
S021 2014-06-09 30-day Notice
S020 2014-05-19 30-day Notice
S019 2014-04-16 Real-time Process
S018 2014-04-23 Panel Track
S017 2014-04-02 30-day Notice
S016
S015
S014 2013-12-06 Real-time Process
S013 2013-09-30 Real-time Process
S012 2013-09-20 30-day Notice
S011 2013-09-16 Normal 180 Day Track
S010 2013-07-26 30-day Notice
S009 2013-07-24 Normal 180 Day Track
S008 2013-07-13 30-day Notice
S007 2013-07-10 30-day Notice
S006 2013-06-04 30-day Notice
S005 2013-05-20 Real-time Process
S004 2013-03-11 30-day Notice
S003 2013-03-04 30-day Notice
S002 2013-02-19 Panel Track
S001 2012-12-05 30-day Notice

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