FreeStyle Libre 14-Day Flash Glucose Monitoring System

FDA Premarket Approval P160030 S046

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 for introducing an alternate higher cavitation mold tooling and injection molding machine at abbott diabetes care supplier for the sensor component manufacturing process. The sensor is a component of the freestyle libre pro flash glucose monitoring system and freestyle libre flash glucose monitoring system

DeviceFreeStyle Libre 14-Day Flash Glucose Monitoring System
Generic NameSensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
ApplicantABBOTT DIABETES CARE INC.
Date Received2020-12-11
Decision Date2021-01-05
PMAP160030
SupplementS046
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
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

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