Enlite Sensor (MMT-7008)

FDA Premarket Approval P150019 S065

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

DeviceEnlite Sensor (MMT-7008)
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150019 Supplement NumberS065 Date Received04/01/2022 Decision Date04/29/2022 Product Codes OYC MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-01
Decision Date2022-04-29
PMAP150019
SupplementS065
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC MINIMED
18000 Devonshire St
northridge, CA 91325 PMA NumberP150019 Supplement NumberS065 Date Received04/01/2022 Decision Date04/29/2022 Product Codes OYC MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Addition Of An Alternate Bioburden And Sterility Contract Testing Laboratory For The Enlite Sensor And The Guardian Sensor (3). The Enlite Sensor Is A Components Of The MiniMed 530G, 630G, Paradigm Real-Time Revel, And IPro2 CGM Systems. The Guardian Sensor (3) Is A Component Of The MiniMed 630G, Guardian Connect, 670G And 770G Systems

Supplemental Filings

Supplement NumberDateSupplement Type
P150019Original Filing
S065 2022-04-01 30-day Notice
S064 2021-11-17 Special (immediate Track)
S063 2021-01-27 Special (immediate Track)
S062 2020-11-03 30-day Notice
S061 2019-11-29 30-day Notice
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

Device IDPMASupp
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00643169694132 P150019 022
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00643169933170 P150019 022

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