iPro™ 2 CGM System with Enlite™ Glucose Sensor

FDA Premarket Approval P150029 S037

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

Approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (cgm) component of the system.

DeviceiPro™ 2 CGM System with Enlite™ Glucose Sensor
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2021-11-17
Decision Date2021-12-17
PMAP150029
SupplementS037
Advisory CommitteeClinical Chemistry
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325

Supplemental Filings

Supplement NumberDateSupplement Type
P150029Original Filing
S037 2021-11-17 Special (immediate Track)
S036 2021-01-27 Special (immediate Track)
S035 2020-11-03 30-day Notice
S034 2019-11-29 30-day Notice
S033 2019-10-17 30-day Notice
S032
S031 2019-08-21 30-day Notice
S030 2019-07-15 30-day Notice
S029 2019-06-19 30-day Notice
S028
S027 2019-02-11 30-day Notice
S026 2019-02-01 30-day Notice
S025 2018-11-07 30-day Notice
S024 2018-11-07 30-day Notice
S023 2018-11-02 30-day Notice
S022 2018-10-15 30-day Notice
S021 2018-07-09 30-day Notice
S020 2018-06-19 30-day Notice
S019 2018-06-07 Special (immediate Track)
S018 2018-03-26 30-day Notice
S017 2018-03-12 30-day Notice
S016 2018-02-09 Real-time Process
S015 2018-02-07 30-day Notice
S014 2017-12-22 30-day Notice
S013 2017-11-24 30-day Notice
S012 2017-10-30 30-day Notice
S011 2017-07-17 30-day Notice
S010 2017-06-22 Real-time Process
S009 2017-05-30 30-day Notice
S008 2017-03-31 30-day Notice
S007
S006 2016-12-23 Real-time Process
S005 2016-12-12 30-day Notice
S004 2016-11-28 30-day Notice
S003 2016-11-28 30-day Notice
S002 2016-11-02 30-day Notice
S001 2016-07-21 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169938076 P150029 010
00763000049997 P150029 010
00763000049492 P150029 010

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.