|
Device | GUARDIAN REAL-TIME MONITOR, MODEL CSS7100. CS7100K |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S123 |
Date Received | 08/30/2012 |
Decision Date | 10/26/2012 |
Product Codes |
MDS OYC |
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 MINOR SOFTWARE MODIFICATIONS IN GUARDIAN® REAL-TIME SYSTEM TO OPTIMIZE THE SHUTDOWN PROCEDURE FOR THE GUARDIAN MONITOR AND TO CORRECT AN ANOMALY THAT ALLOWED ACCESS OF OUT-OF-BOUNDS POINTER ERRORS. |