Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S122 |
Date Received | 08/23/2012 |
Decision Date | 09/18/2012 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING PROCESS CHANGE WHICH WILL INCORPORATE THE ADDITION OF PROCESS WATER TO A ONCE-DILUTED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF-SENSORGLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE DEVICES. |
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