|
Device | DEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S073 |
Date Received | 05/10/2010 |
Decision Date | 06/29/2010 |
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 |
Approval Order Statement APPROVAL FOR A CHANGE TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES (DEV-0016). THE SOFTWARE VERSION 1.0A IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS AND CORRECTION OF THREE MINOR ANOMALIES. |