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 Paradigm Real-Time Revel System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S033 |
Date Received | 11/24/2017 |
Decision Date | 12/21/2017 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a new sterilization site for the Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of MiniMed 530G System, MiniMed Paradigm Real-Time Revel System, and MiniMed iPro2 CGM System with Enlite Sensor. The Guardian Sensor (3) is a component of MiniMed 630G System with SmartGuard and the MiniMed 670G System. |
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