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 | MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S110 |
Date Received | 02/09/2012 |
Decision Date | 07/17/2012 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LANGUAGE AND PICTORIAL CHANGES TO THE INSTRUCTIONS FORUSE (IFU) OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002) TO MAKE IT CONSISTENT WITH THE LANGUAGE THAT IS INCLUDED IN THE CURRENTLY APPROVED PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP USER GUIDES. THE SOF-SENSOR, PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL- TIME SYSTEM, GUARDIAN REAL-TIME SYSTEM, AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSEMONITORING (CGM) SYSTEM. |
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