|
Device | CARELINK IPRO THERAPY MANAGEMENT SOFTWARE |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S124 |
Date Received | 09/18/2012 |
Decision Date | 11/16/2012 |
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 SOFTWARE MODIFICATIONS TO THE CARELINK IPRO THERAPYMANAGEMENT SOFTWARE (MMT-7340) FROM VERSION 1.4 TO VERSION 1.5A. THE CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MMT-7340) IS A COMPONENT OF THE IPRO2 PROFESSIONAL CGM SYSTEM (MMT-7745). |