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 NumberS042
Date Received10/31/2014
Decision Date01/29/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR USE OF A THICKER DOUBLE-SIDED TAPE ON THE SOF-SENSOR (MODEL MMT-7002, MMT-7003 AND ENLITE SENSOR (MMT-7008) BASE AS WELL AS CHANGE IN THECONVERTER/DISTRIBUTOR OF THE TAPE. THE SOF-SENSOR (MODEL MMT-7002, MMT-7003) IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, AND IPRO2 PROFESSIONAL CGM SYSTEMS AND THE ENLITE GLUCOSE SENSOR (MMT-7008) 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.
-
-