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 | ENLITE GLUCOSE SENSOR |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S025 |
Date Received | 06/03/2014 |
Decision Date | 07/02/2014 |
Product Code |
OZO |
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 CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO ADD A NEW SENSOR FABRICATION CONFIGURATION TO INCLUDEA 48-UP SENSOR MASK. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. |
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