|
Device | CARELINK PERSONAL SOFTWARE |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S043 |
Date Received | 12/04/2008 |
Decision Date | 01/27/2009 |
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 AN UPDATED VERSION OF THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES (MMT-7333) THAT CORRECTS PREVIOUSLY IDENTIFIED ANOMALIES. |