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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 | S067 |
Date Received | 01/04/2010 |
Decision Date | 08/29/2011 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE RAW MATERIAL USED IN THE ADHESIVE PATCH OF THE GLUCOSE SENSOR COMPONENT (MODELS MMT-7002 AND MMT-7003) OF THE DEVICE. |