iPro2 CGM System

Sensor, Glucose, Invasive

FDA Premarket Approval P150029 S033

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

Supplier of the glucose oxidase used in the fabrication of the enlite sensor and guardian sensor (3) moved their manufacturing facility from one location to another within the united kingdom.

DeviceiPro2 CGM System
Classification NameSensor, Glucose, Invasive
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2019-10-17
Decision Date2019-11-15
PMAP150029
SupplementS033
Product CodeMDS
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325

Supplemental Filings

Supplement NumberDateSupplement Type
P150029Original Filing
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
00763000049997 P150029 010
00763000049492 P150029 010
00643169938076 P150029 010

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