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 GLUCOSE SENSOR, SOF 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 | S154 |
Date Received | 04/11/2014 |
Decision Date | 07/10/2014 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO LOWER THE PURITY SPECIFICATION LIMIT FOR THE CHROMIUMLAYER ON ENLITE¿ GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOF¿ GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM REAL-TIME REVEL SYSTEM. |
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