Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated

FDA Premarket Approval P160030 S026

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

Higher volume preparations of stock solutions used to prepare freestyle libre sensors, and qualification of a new supplier for reagents used for freestyle libre sensor lot release testing as well as increased shelf life for those reagents. The freestyle libre sensor is a component of the freestyle libre and freestyle libre pro continuous glucose monitoring systems.

DeviceFreestyle Libre Flash Glucose Monitoring System
Classification NameSensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
Generic NameSensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
ApplicantABBOTT DIABETES CARE INC.
Date Received2018-08-20
Decision Date2018-09-19
PMAP160030
SupplementS026
Product CodePZE
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 Dr. alameda, CA 94502-7000

Supplemental Filings

Supplement NumberDateSupplement Type
P160030Original Filing
S052 2022-12-19 Normal 180 Day Track No User Fee
S051 2022-04-01 30-day Notice
S050 2022-02-18 30-day Notice
S049 2022-02-01 30-day Notice
S048 2021-12-20 Normal 180 Day Track No User Fee
S047 2021-02-23 Real-time Process
S046 2020-12-11 30-day Notice
S045 2020-11-27 30-day Notice
S044
S043 2020-07-01 30-day Notice
S042 2020-04-01 Normal 180 Day Track No User Fee
S041 2020-03-20 30-day Notice
S040 2019-11-20 30-day Notice
S039
S038 2019-08-15 30-day Notice
S037 2019-07-18 30-day Notice
S036 2019-07-12 30-day Notice
S035 2019-05-30 30-day Notice
S034
S033 2019-04-10 30-day Notice
S032 2019-02-04 30-day Notice
S031
S030
S029 2018-12-03 Real-time Process
S028 2018-10-31 Normal 180 Day Track
S027 2018-09-27 Normal 180 Day Track
S026 2018-08-20 30-day Notice
S025 2018-08-09 Normal 180 Day Track No User Fee
S024 2018-07-23 30-day Notice
S023 2018-06-18 Real-time Process
S022 2018-06-08 30-day Notice
S021
S020 2018-05-29 30-day Notice
S019 2018-05-01 30-day Notice
S018 2018-05-01 Real-time Process
S017 2018-04-10 Panel Track
S016 2018-03-29 30-day Notice
S015 2018-03-19 30-day Notice
S014 2018-03-12 Normal 180 Day Track
S013 2018-03-05 30-day Notice
S012 2018-03-01 30-day Notice
S011 2018-03-01 30-day Notice
S010 2018-02-26 Normal 180 Day Track
S009
S008 2017-12-01 30-day Notice
S007 2017-12-01 Real-time Process
S006 2017-12-01 30-day Notice
S005 2017-11-27 30-day Notice
S004 2017-11-27 30-day Notice
S003 2017-11-20 30-day Notice
S002 2017-11-01 30-day Notice
S001 2017-10-20 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
30357599000197 P160030 000
30357599000852 P160030 000
30357599000241 P160030 000
30357599000227 P160030 000
30357599000210 P160030 000
30357599000203 P160030 000
00357599000059 P160030 010
57599-0002-00 P160030 017
30357599000982 P160030 017
30357599000975 P160030 017
30357599002009 P160030 017
30357599001026 P160030 017
30357599001019 P160030 017
57599-0000-97 P160030 017
00357599000042 P160030 031

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