Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

New Search Back to Search Results
Note: 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.
 
DeviceFreeStyle Libre 14-day Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ApplicantAbbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda, CA 94502
PMA NumberP160030
Supplement NumberS041
Date Received03/20/2020
Decision Date04/13/2020
Product Code PZE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Update to the in-process optical setup and image processing for the vision systems that verify three Critical Quality Attributes of the glucose sensor puck. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
-
-