FreeStyle Libre Pro Flash Glucose Monitoring System

FDA Premarket Approval P150021 S054

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 to add an alternate manufacturing site for sensor container assembly and finished sensor kit packing. The sensor container and sensor kit are components of the freestyle libre pro flash continuous glucose monitoring (cgm) device

DeviceFreeStyle Libre Pro Flash Glucose Monitoring System
Generic NameSensor, Glucose, Invasive
ApplicantAbbott Diabetes Care Inc.
Date Received2021-09-03
Decision Date2021-09-30
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Diabetes Care Inc. 1360 South Loop Rd. alameda, CA 94502

Supplemental Filings

Supplement NumberDateSupplement Type
P150021Original Filing
S054 2021-09-03 30-day Notice
S053 2021-02-23 Real-time Process
S052 2020-12-11 30-day Notice
S051 2020-11-27 30-day Notice
S049 2020-07-01 30-day Notice
S048 2020-03-20 30-day Notice
S047 2019-11-20 30-day Notice
S045 2019-08-15 30-day Notice
S044 2019-07-18 30-day Notice
S043 2019-07-12 30-day Notice
S042 2019-05-30 30-day Notice
S041 2019-04-10 30-day Notice
S040 2019-02-04 30-day Notice
S038 2018-12-26 Real-time Process
S037 2018-12-03 Real-time Process
S036 2018-10-31 Normal 180 Day Track
S035 2018-09-27 Normal 180 Day Track
S034 2018-08-29 30-day Notice
S033 2018-08-20 30-day Notice
S032 2018-07-23 30-day Notice
S031 2018-06-18 Real-time Process
S030 2018-06-08 30-day Notice
S029 2018-05-29 30-day Notice
S028 2018-05-01 30-day Notice
S027 2018-05-01 Real-time Process
S026 2018-03-29 30-day Notice
S025 2018-03-19 30-day Notice
S024 2018-03-12 Normal 180 Day Track
S023 2018-03-05 30-day Notice
S022 2018-03-01 30-day Notice
S021 2018-03-01 30-day Notice
S019 2018-01-23 30-day Notice
S018 2018-01-16 30-day Notice
S017 2017-12-01 30-day Notice
S016 2017-12-01 Real-time Process
S015 2017-11-27 30-day Notice
S014 2017-11-27 30-day Notice
S013 2017-11-20 30-day Notice
S012 2017-09-25 Normal 180 Day Track No User Fee
S011 2017-08-02 Real-time Process
S010 2017-06-12 30-day Notice
S009 2017-05-22 135 Review Track For 30-day Notice
S008 2017-05-19 135 Review Track For 30-day Notice
S007 2017-05-02 Real-time Process
S006 2017-04-03 Normal 180 Day Track
S005 2017-03-30 30-day Notice
S004 2016-12-16 135 Review Track For 30-day Notice
S003 2016-12-14 30-day Notice
S001 2016-11-01 Normal 180 Day Track


Device IDPMASupp
30357599716876 P150021 000
30357599715626 P150021 000
30357599715619 P150021 000
57599-0715-55 P150021 000
30357599000418 P150021 000

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