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Device | MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S103 |
Date Received | 11/14/2011 |
Decision Date | 06/19/2012 |
Product Codes |
MDS OYC |
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 A MANUFACTURING PROCESS CHANGE TO INCORPORATE THE ADDITION OF PROCESS WATER TO A USED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF SENSOR GLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME SYSTEM, THE GUARDIAN REAL-TIME SYSTEM, THE CGMS IPRO SYSTEM AND THE CGMS IPRO2 SYSTEM. |