|
Device | MINIMED 530G INSULIN PUMPS; ENLITE SENSOR |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S010 |
Date Received | 02/06/2014 |
Decision Date | 03/06/2014 |
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 ADDITION OF AN ALTERNATE WAREHOUSE FACILITY FOR THE HANDLING OF RAW MATERIALS INCLUDING SUBASSEMBLIES AND COMPONENTS FOR THE MINIMED 530G INSULIN PUMP (MMT-551, MMT-751). THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM. |