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 System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S061 |
Date Received | 11/29/2019 |
Decision Date | 12/19/2019 |
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 Update sterilization procedure for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor and Guardian Sensor (3) are components of the MiniMed 530G, 630G, and 670G Systems; the Paradigm Real-Time Revel System; the iPro2 CGM System; and the Guardian Connect System. |
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