|
Device | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S082 |
Date Received | 12/28/2015 |
Decision Date | 01/27/2016 |
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 THE APPROVAL OF A TRANSITION OF THE MANUFACTURING OF THE TYVEK LIDS USED FOR PACKAGING THE ENLITE SENSOR COMPONENT FROM THE SUPPLIER'S FACILITY IN PHILADELPHIA TO OSHKOSH, WISCONSIN. ADDITIONALLY, THE FACILITY TRANSITION INCLUDES NEW MANUFACTURING ASSETS INCLUDING COATER AND DIE CUT LID PRESS. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEMS. |