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 | PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S177 |
Date Received | 12/30/2014 |
Decision Date | 01/22/2016 |
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 | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ANNEALING PROCESS AND CHEMICAL EXPOSURE DURABILITY TEST FOR THE SMOKE COLOR IN THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-753, MMT-753K) AND MINIMED 530G INSULIN PUMPS (MMT-751). THESE ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS, RESPECTIVELY. |
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