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 NumberS002
Date Received11/07/2013
Decision Date12/06/2013
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement TypeSpecial (Immediate Track)
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF PRODUCT SPECIFICATION REQUIREMENTS FOR THE GLUCOSE OXIDASE MATERIAL USED IN THE SOF-SENSORS (MODELS: MMT-7002 AND MMT-7003) AND THE ENLITE SENSOR (MODEL: MMT-7008).
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
-
-