FreeStyle Libre Pro Flash Glucose Monitoring System

FDA Premarket Approval P150021 S057

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

DeviceFreeStyle Libre Pro Flash Glucose Monitoring System
Generic NameSensor, Glucose, Invasive
ApplicantAbbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS057 Date Received04/01/2022 Decision Date04/28/2022 Product Code 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 Date2022-04-28
PMAP150021
SupplementS057
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Diabetes Care Inc.
1360 South Loop Rd.
alameda, CA 94502 PMA NumberP150021 Supplement NumberS057 Date Received04/01/2022 Decision Date04/28/2022 Product Code 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 To Update An Analytical Method Used To Evaluate A Raw Ingredient Of The Glucose Sensor Component And To Introduce The Evaluation Process To An Additional Manufacturing Site. The Glucose Sensor Is A Component Of The FreeStyle Libre 14-Day And FreeStyle Libre Pro Glucose Monitoring Systems

Supplemental Filings

Supplement NumberDateSupplement Type
P150021Original Filing
S057 2022-04-01 30-day Notice
S056 2022-02-18 30-day Notice
S055 2022-02-01 30-day Notice
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
S050
S049 2020-07-01 30-day Notice
S048 2020-03-20 30-day Notice
S047 2019-11-20 30-day Notice
S046
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
S039
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
S020
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
S002
S001 2016-11-01 Normal 180 Day Track

NIH GUDID Devices

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

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