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 REVEL INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S112 |
Date Received | 02/24/2012 |
Decision Date | 04/27/2012 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE MODIFICATIONS (VERSION 2.5A) AND RELATED LABELING MODIFICATIONS FOR THE PARADIGM REAL-TIME REVEL PUMP (MODELS MMT-532, MMT-723, MMT-523K, MMT723K). THE PARADIGM REVEL INSULIN PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME REVEL SYSTEM. |
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