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 | PARADIGUM REAL TIME PUMP; PARADIGUM REAL TIME REVEL INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S135 |
Date Received | 07/24/2013 |
Decision Date | 08/23/2013 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF LABELING CHANGES TO THE USER GUIDE AND TO THE TWO PACKAGE INSERTS (ERRATA SHEETS) FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, AND MMT-722K), AND FOR THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEMS. |
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