|
Device | ENLITE SENSOR |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S028 |
Date Received | 06/24/2014 |
Decision Date | 07/22/2014 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Clinical Trials | NCT01112696
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE NEEDLE HUB ASSEMBLY TOOLING WHICH IS USED IN THE MANUFACTURE OF THE ENLITE SENSOR (MMT-7008). THE ENLITE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |