MINILINK REAL TIME TRANSMITTER

Sensor, Glucose, Invasive

FDA Premarket Approval P150019 S025

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

Add a new mold and press during the supplier’s manufacture of the glucose sensing transmitter/recorder bottom cover component of various medtronic glucose monitoring systems.

DeviceMINILINK REAL TIME TRANSMITTER
Classification NameSensor, Glucose, Invasive
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2016-11-28
Decision Date2016-12-19
PMAP150019
SupplementS025
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
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
00643169693814 P150019 020
00643169694132 P150019 022
00643169694149 P150019 022
00643169694156 P150019 022
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00643169933170 P150019 022

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