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

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


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 GLUCOSE SENSOR
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS058
Date Received01/26/2015
Decision Date06/09/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN THE PRE-DOSING PROCESS OF THE ENLITE SENSORADHESIVE PATCH. THE ENLITE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
-
-