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 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S166 |
Date Received | 10/30/2014 |
Decision Date | 05/13/2015 |
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 CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION. |
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