Paradigm Real-Tme Revel System

Sensor, Glucose, Invasive

FDA Premarket Approval P150019 S060

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.

DeviceParadigm Real-Tme Revel System
Classification NameSensor, Glucose, Invasive
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2019-10-17
Decision Date2019-11-15
PMAP150019
SupplementS060
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
P150019Original Filing
S060 2019-10-17 30-day Notice
S059
S058 2019-08-21 30-day Notice
S057 2019-07-15 30-day Notice
S056 2019-06-19 30-day Notice
S055
S054 2019-02-11 30-day Notice
S053 2019-02-01 30-day Notice
S052 2018-11-07 30-day Notice
S051 2018-11-07 30-day Notice
S050 2018-11-07 30-day Notice
S049 2018-11-02 30-day Notice
S048 2018-10-15 30-day Notice
S047 2018-10-01 30-day Notice
S046 2018-07-16 30-day Notice
S045 2018-07-09 30-day Notice
S044 2018-06-19 30-day Notice
S043 2018-06-07 Special (immediate Track)
S042 2018-04-30 30-day Notice
S041 2018-03-26 30-day Notice
S040 2018-03-12 30-day Notice
S039 2018-02-09 Real-time Process
S038 2018-02-07 30-day Notice
S037 2018-01-29 30-day Notice
S036 2018-01-29 30-day Notice
S035 2017-12-22 30-day Notice
S034 2017-12-20 Real-time Process
S033 2017-11-24 30-day Notice
S032 2017-10-30 30-day Notice
S031 2017-07-17 30-day Notice
S030 2017-05-30 30-day Notice
S029 2017-04-10 30-day Notice
S028 2017-03-31 30-day Notice
S027 2016-12-23 Real-time Process
S026 2016-11-28 30-day Notice
S025 2016-11-28 30-day Notice
S024 2016-11-09 Real-time Process
S023 2016-11-02 30-day Notice
S022 2016-09-30 Real-time Process
S021
S020 2016-09-19 30-day Notice
S019
S018 2016-07-26 30-day Notice
S017
S016 2016-06-15 135 Review Track For 30-day Notice
S015
S014 2016-04-27 135 Review Track For 30-day Notice
S013 2016-03-28 30-day Notice
S012 2016-03-25 30-day Notice
S011 2016-03-25 30-day Notice
S010 2016-03-09 30-day Notice
S009 2016-03-07 30-day Notice
S008 2016-02-23 30-day Notice
S007 2016-02-17 Real-time Process
S006 2016-02-17 30-day Notice
S005 2016-02-17 30-day Notice
S004 2016-02-17 30-day Notice
S003 2016-02-17 30-day Notice
S002 2016-02-12 30-day Notice
S001 2016-02-12 30-day Notice

NIH GUDID Devices

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