|
Device | CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S076 |
Date Received | 06/07/2010 |
Decision Date | 11/17/2010 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODIFICATIONS OF THE COATING PROCESS FROM THE SPIN COATING PROCESS TO THE SLOT COATING PROCESS, AND THE ADHESION PROMOTER (AP) SOLUTION. |