|
Device | MINIMED 530G INSULIN PUMP |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S016 |
Date Received | 03/06/2014 |
Decision Date | 06/03/2014 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE SOFTWARE TO THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751). THESE CHANGES INCLUDE CORRECTIONS FOR TWO MOTOR ERROR ANOMALIES AND THREE THRESHOLD SUSPEND ANOMALIES, AND ENHANCEMENTS FOR THE THRESHOLD SUSPEND FEATURE, INSULIN VALUE SETTING, AND MERGED COMMON CODE BASE. |