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 | S026 |
Date Received | 11/28/2016 |
Decision Date | 12/27/2016 |
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 laser cutting system used during manufacture of the Enlite Sensor at the contract manufacturer. The Enlite Sensor is a component of the MiniMed 530G System, the MiniMed 630G System With SmartGuard, the Paradigm Real-Time Revel System, and the iPro2 CGM System with Enlite Sensor, respectively. |
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