|
Device | MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S090 |
Date Received | 11/08/2010 |
Decision Date | 01/07/2011 |
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 A MODIFICATION TO THE DESIGN SPECIFICATION OF THE LUMEN TUBING USED IN THE MANUFACTURING PROCESS OF THE GLUCOSE SENSOR TO ALLOW FOR LESS DIMENSIONAL VARIATION IN THE TUBING SUPPLIED BY THE TUBING VENDOR. |