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 AND 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 | S113 |
Date Received | 02/27/2012 |
Decision Date | 04/18/2012 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPERCAPACITOR, A COMPONENT USED ON THE INTERFACE BOARDS OF THE PARADIGM REAL-TIME PUMP (MODELS MMT-522, -522K, -722, 722K) AND PARADIGM REAL-TIME REVEL PUMP (MODELS MMT-523, -523K, -723, -723K) WHICH ARE COMPONENTS OF THE DEVICES. |
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