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.
 
DeviceENLITE SENSOR
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS073
Date Received10/19/2015
Decision Date11/18/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
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  
TO USE A RECENTLY APPROVED SENSOR BASE COMPONENT ON MPROC (MEDTRONIC PUERTO RICO OPERATION COMPANY) ENLITE SENSORS MANUFACTURING LINE, TO INCREASE THE NUMBER OF COMPONENTS (BASES AND CAPS) TREATED PER PLASMA CLEANING CYCLE AND TO INCREASE POST-PLASMA SHELF LIFE THE THE TREATED COMPONENTS. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
-
-