|
Device | MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SOFTWARE SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S099 |
Date Received | 10/21/2011 |
Decision Date | 12/20/2011 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR SOFTWARE CHANGES TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES MMT-7333 V5.7A FOR USE WITH THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM. |