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 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 NumberS015
Date Received03/19/2018
Decision Date04/17/2018
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  
Introduce a new mold and press used to make the Connector Body and Connector Trace components, which are a part of the FreeStyle Libre and FreeStyle Libre Pro Flash Glucose Monitoring Systems.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
-
-