iPro2 CGM System with Enlite Sensor

FDA Premarket Approval P150029 S035

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 manufacturing changes related to bioburden testing for the enlite sensor and guardian sensor (3). The enlite sensor is component of the minimed 530g system, the minimed 630g system, the paradigm real-time revel system, and the ipro2 cgm system. The guardian sensor (3) is component of the minimed 670g system, the guardian connect system, and the minimed 630g system with smartguard

DeviceiPro2 CGM System with Enlite Sensor
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2020-11-03
Decision Date2020-12-01
PMAP150029
SupplementS035
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
S038 2022-04-01 30-day Notice
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
00763000049492 P150029 000
00643169938076 P150029 010
00763000049997 P150029 010
00763000049492 P150029 010

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