|
Device | ENLITE GLUCOSE SENSORS |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S072 |
Date Received | 08/10/2015 |
Decision Date | 01/21/2016 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 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 OF AN ALTERNATE SUPPLIER OF GLUCOSE OXIDASE USED IN THE FABRICATION OF THE ENLITE GLUCOSE SENSOR THAT IS A COMPONENT OF THE MINIMED 530G SYSTEM. |