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. |
|
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 | S057 |
Date Received | 01/26/2015 |
Decision Date | 02/27/2015 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REMOVAL OF A CONDUCTIVITY TEST FOR A SOLUTION USED ON THE MANUFACTURE OF ENLITE SENSORS, THE CREATION OF A NEW PART NUMBER FOR THIS SOLUTION AND THE REMOVAL OF ALTERNATE PART NUMBER ALLOWED FOR ENLITE SENSORS MANUFACTURE. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. |
|
|